Biomet SpinalPak / OrthoPak 106130-22Recalls & reported problems

Summary

The FDA's MAUDE database contains 101 adverse event reports that list this exact device (DI 00880304820852), received between Mar 26, 2019 and Aug 12, 2026 — classified as 100 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (91 reports).

4 other recalls cover devices cleared under the same FDA submission (P850022); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 101 reports, in the reporter's own words as published by the FDA.

• InjuryAug 12, 2026Patient-Device Incompatibility

  It was reported that the patient experienced skin irritation with the 63B Electrodes. The patient stated that she thinks she let her skin heal prior to using the electrodes. The patient only wore the electrodes for a little while, not all day. The patient discontinued use of the bone growth stimulator due to the skin irritation issue and will be prescribed a different unit. No further consequences were reported.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 50227787 ↗
• InjuryJun 16, 2026Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT REPORTED THAT THE 63B ELECTRODES CAUSED A RASH AND SEEMED TO BURN THE PATIENT¿S SKIN. THE PATIENT CLAIMED SHE COULD FEEL THE ELECTRIC CURRENT RUNNING THROUGH THE WIRES AND FELT A BURN LIKE FIRE ON HER NECK WHEN SHE TREATED. THE PATIENT ADVISED THAT SHE HAD SKIN ISSUES AND PAUSED TREATMENT FOR HER SKIN TO HEAL FROM TIME TO TIME. THE DERMATOLOGIST GAVE HER 2.5% HYDROCORTISONE CREAM TO HEAL THE SKIN BETWEEN TREATMENTS BUT ADVISED THE ISSUE WOULD NOT FULLY HEAL UNLESS SHE STOPPED TREATING. THE PATIENT ADVISED SHE NEVER PERFORMED A TIME TEST WHEN SWITCHING FROM ONE ELECTRODE TO THE NEXT. SHE TREATED 24 HOURS PER DAY, 7 DAYS PER WEEK UNTIL MARCH. THE PATIENT SAW THE SURGEON IN LATE MARCH, AND THE SURGEON RECOMMENDED TREATING AS MUCH AS THE PATIENT CAN TOLERATE. THE PATIENT SPOKE WITH THE PRESCRIBING DOCTOR AND A DERMATOLOGIST WHO SAID THAT NOT ONLY ARE THE 63B ELECTRODES CAUSING A SEVERE REACTION, BUT IT IS ALSO THE ELECTRICAL CURRENT THAT IS CAUSING HER SKIN TO BURN AND BECOME DISCOLORED AND EXTREMELY SORE. THE PATIENT¿S DOCTOR ULTIMATELY DECIDED TO PRESCRIBE AN ALTERNATIVE DEVICE DUE TO THE PATIENT¿S ONGOING SKIN IRRITATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Burn(s); Rash; Skin Discoloration

  MAUDE report 25517545 ↗
• InjuryNov 21, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE SALES REP ADVISED THAT THE 63B ELECTRODES IRRITATED THE PATIENT. THE PATIENT WAS CALLED AND ADVISED THAT THE 63B ELECTRODES IRRITATED HIS SKIN. THE SKIN WAS RED, ITCHY, AND HAS WELTS. HE CALLED HIS DOCTOR'S NURSE AND THEY TOLD HIM TO CALL HIS SALES REP AND USE HYDROCORTISONE IF NEEDED AND THIS DID NOT HELP. THE PATIENT USED NOTHING ON HIS SKIN SO IT WOULD DRY OUT. THE PATIENT HAS SENSITIVE SKIN AND AN ALLERGY TO LATEX. 72R ELECTRODES WERE SHIPPED TO THE PATIENT. RETURN NOTED.

  Patient problems: Hypersensitivity/Allergic reaction; Rash; Skin Inflammation/ Irritation

  MAUDE report 23623893 ↗
• InjuryMay 23, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED BY THE PATIENT THAT SHE IS GETTING A SKIN IRRITATION FROM THE 63B ELECTRODES. THE PATIENT CHANGES ELECTRODES AND ROTATES THEM EVERY DAY. THE PATIENT DID THE TIME TEST AND AFTER THE FIRST HOUR SHE HAD A SKIN IRRITATION. THE SKIN WAS RED AND ITCHY AND A RED MARK AROUND THE ELECTRODES. THE PATIENT DEVELOPED WELTS AND BLISTERS. THE PATIENT DID NOT CONTACT HER DOCTOR. THE SKIN WAS CLEAN WITH SOAP AND WATER. THE PATIENT DID NOT APPLY ANYTHING TO THE AFFECTED AREA. THE PATIENT STOPPED USING THE 63B ELECTRODES AROUND (B)(6) 2025. LATER, THE PATIENT STATED THAT THE DOCTOR ADVISED TO STOP USING THE UNIT DUE TO SKIN IRRITATION WITH 63B ELECTRODES. THE PATIENT ADVISED SHE HAD AN IRRITATION TO BOTH TYPES OF ELECTRODES. SHE SPOKE WITH HER DOCTOR AND WHO SAID SHE CAN DISCONTINUE IF SHE WANTS. THE PATIENT WILL CONDUCT TIME-TEST USING ELECTRODES AS ADVISED BY CUSTOMER SERVICE REPRESENTATIVE. NO FURTHER CONSEQUENCES WERE REPORTED. 63B ELECTRODES WERE NOT RETURNED FOR FURTHER EVALUATION.

  Patient problems: Blister; Skin Inflammation/ Irritation

  MAUDE report 22079962 ↗
• InjuryMar 25, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE ELECTRODES PEELED OFF THE PATIENT¿S SKIN. THE PATIENT¿S SALES REPRESENTATIVE RECOMMENDED SWITCHING THE PATIENT TO THE BONE HEALING SYSTEM. A NEW PRESCRIPTION WAS RECEIVED FORM THE PATIENT¿S PHYSICIAN STATING THAT THE PATIENT WAS BEING SWITCHED FROM THE ORTHOPAK DUE TO SKIN SENSITIVITY ISSUES.

  Patient problems: Peeling; Skin Inflammation/ Irritation

  MAUDE report 21690022 ↗
• InjuryMar 13, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED BY THE PRODUCT SURVEILLANCE SPECIALIST THAT THE PATIENT INDICATED THAT THEY DEVELOPED RASH/IRRITATION WHILE USING REPLACEMENT 63B ELECTRODES. THE PATIENT INDICATED THAT THEY WERE EXPERIENCING IRRITATION WITH 63B ELECTRODES. THE PATIENT DID NOT CONTACT THEIR DOCTOR OR DID NOT USE ANY OINTMENT/ CREAMS ON THE AFFECTED AREA. THE CUSTOMER SERVICE REPRESENTATIVE ADVISED THE PATIENT TO CLEAN THE AREA WITH SOAP AND WATER AND CONDUCT A TIME-TEST AFTER THE SKIN HEALS COMPLETELY. LATER, THE CUSTOMER SERVICE REPRESENTATIVE CALLED THE PATIENT REGARDING SKIN IRRITATION AND HAD TO LEAVE A VOICEMAIL. LATER, THE PATIENT CALLED BACK AND STATED THAT SHE WAITED FOR TWO WEEKS FOR HER SKIN TO HEAL AFTER THE ISSUE WITH 72R ELECTRODES BEFORE USING 63B ELECTRODES. AFTER ONE HOUR OF USING 63B ELECTRODES, THE PATIENT DEVELOPED RASH, HIVES LIKE ALLERGY AND SKIN WAS RED, ITCHY. HER SKIN IS VERY SENSITIVE TO ALL ADHESIVES INCLUDING PAPER TAPE AND EKG ELECTRODES. SHE ALSO HAS ECZEMA. THE PATIENT HAD NOT USED ANY OINTMENT ON THE AREA AND DID SPEAK TO HER DOCTOR. THE DOCTOR SUGGESTED SHE CONTACT THE SALES REPRESENTATIVE IF HE CAN HELP WITH ANY ALTERNATIVE ELECTRODES AND THE DOCTOR WOULD SPEAK TO RE

  Patient problems: Hypersensitivity/Allergic reaction; Rash; Skin Inflammation/ Irritation

  MAUDE report 21595520 ↗
• InjuryFeb 18, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE PATIENT THAT SHE EXPERIENCED SKIN IRRITATION AND PAIN WHILE USING THE 63B ELECTRODES. LATER, THE PATIENT INDICATED THAT IT FELT LIKE BURNING SENSATION IN NECK WITH EXCRUCIATING PAIN, SENSITIVE TOUCH AND DISCOLORATION. THE PATIENT WENT TO URGENT CARE AND WAS PRESCRIBED MOMETASONE FUROATE CREAM AND HYDROXYZINE HCL 25MG TABS. NO FURTHER CONSEQUENCES ARE REPORTED. THE 63B ELECTRODES WERE NOT RETURNED FOR FURTHER EVALUATION.

  Patient problems: Burn(s); Pain; Skin Inflammation/ Irritation

  MAUDE report 21394320 ↗
• InjuryJan 29, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A RASH AND SKIN IRRITATION WITH THE 63B ELECTRODES. SOMETIMES THE IRRITATION IS AROUND THE ELECTRODES AND OTHER TIMES IT IS UNDERNEATH THE ELECTRODES. IT WAS LATER REPORTED THAT THE PATIENT¿S SKIN IRRITATION CONSISTED OF A RASH AND REDNESS, NO BLISTERS OR WELTS. THE PATIENT CONTACTED A TELE-HEALTH DOCTOR FOR THE SKIN IRRITATION AND WAS PRESCRIBED A STEROID OINTMENT FOR THE RASH. THE PATIENT STATED THAT THE SKIN IRRITATION WAS MUCH BETTER AFTER USING THE OINTMENT. THE DOCTOR ADVISED TO USE VASELINE FOR SKIN DRYNESS AND ITCHINESS. THE PATIENT NOTED THAT SHE IS USING THE ELECTRODES ON HER MIDDLE TO LOWER BACK. THE PATIENT WAS UNSURE IF THE RASH WAS CAUSED BY ONLY THE 63B ELECTRODES OR SOMETHING ELSE. THE PATIENT REQUESTED ADDITIONAL 63B ELECTRODES TO CONTINUE TREATMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Erythema; Skin Inflammation/ Irritation

  MAUDE report 21265804 ↗
• InjuryOct 28, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT HAD AN ALLERGIC REACTION TO THE 63B ELECTRODES. THE PATIENT STATED THAT HE WAS IN THE PROCESS OF BEING SWITCHED TO THE BHS AFTER DISCUSSING THE ISSUE WITH HIS SALES REPRESENTATIVE. IT WAS LATER REPORTED THAT THE PATIENT DECIDED TO PAUSE TREATMENT DUE TO THE IRRITATION AND IS WAITING UNTIL HIS NOVEMBER APPOINTMENT WITH HIS DOCTOR TO GET A SECOND OPINION. NO FURTHER INFORMATION WAS PROVIDED. IT WAS LATER REPORTED THAT THE PATIENT SPOKE WITH HIS SURGEON ON (B)(6)2024 AND WAS TOLD HE DID NOT NEED ELECTRICAL STIMULATION. THE SURGEON DID NOT THINK IT WAS NECESSARY. THE PATIENT STATED THAT WE WOULD BE DISCARDING THE REMAINING ELECTRODES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 20545004 ↗
• InjuryAug 23, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED BY THE PATIENT THAT 63B ELECTRODES CAUSED SKIN IRRITATION. THE PATIENT CONTACTED THEIR PHYSICIAN AND WERE ADVISED TO STOP TREATING. NO FURTHER INFORMATION HAS BEEN REPORTED. THE 63B ELECTRODES HAS NOT BEEN RETURNED FOR EVALUATION.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 20052099 ↗
• InjuryJul 15, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT HAD SKIN IRRITATION WITH THE 63B ELECTRODES. THE PATIENT STATED THAT THE IRRITATION IS NOT BAD AND IF IT HAPPENS, SHE PAUSES FOR A COUPLE DAYS AND THEN CONTINUES TREATING AS SHE IS COMMITTED TO FINISHING HER TREATMENT REGARDLESS OF ANY IRRITATION. CUSTOMER SERVICE CALLED THE PATIENT AND FOUND THAT THE PATIENT HAS VERY SENSITIVE SKIN. THE 63B ELECTRODES ARE NOT AS BAD AS THE 72R ELECTRODES. THE PATIENT HAS BEEN MOVING AND CHANGING THE ELECTRODES DAILY. THE PATIENT DOES NOT CURRENTLY HAVE A REACTION BUT EVERY TIME THE REACTION OCCURS, SHE BLISTERS AND SOMETIMES HAS OPEN WOUNDS. THE PATIENT IS NOT USING COVER PATCHES. CUSTOMER SERVICE ADVISED THE PATIENT TO CHANGE AND ROTATE HER ELECTRODES TWICE DAILY.

  Patient problems: Blister; Skin Inflammation/ Irritation

  MAUDE report 19744353 ↗
• InjuryMay 1, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT WHO STATED THAT SHE IS ITCHING WITH THE 63B ELECTRODES. THE SKIN IS RED AND ITCHY. THE PATIENT WANTS TO CONTINUE TREATMENT. THE PATIENT IS ALLERGIC TO ADHESIVE AND LATEX. THE PATIENT DID NOT SPEAK TO HER DOCTOR THE AREA IS CLEAN WITH SOAP AND WATER. THE PATIENT CHANGES HER ELECTRODES EVERY DAY. THE PATIENT HAS NOT APPLIED ANYTHING TO THE AFFECTED AREA. THE PATIENT REQUESTED 63B ELECTRODES AND COVER PATCHES. I DID REMIND THE PATIENT THAT THE COVER PATCHES HAS ADHESIVE. THE PATIENT STATED THAT SHE WANTS TO CONTINUE USING THE DEVICE. NO FURTHER CONSEQUENCES HAVE BEEN REPORTED AT THIS TIME. MDR REPORT #: MW5153574. REPORTER CALLING, STATING SHE HAD SPINAL SURGERY IN HER NECK ON (B)(6) 2024, AND WAS DISCHARGED TWO DAYS LATER, ON (B)(6) 2024. REPORTER STATES THAT UPON DISCHARGE SHE WAS INSTRUCTED TO USE A BIOMET ORTHOPAK BONE GROWTH STIMULATOR FOR SIX MONTHS. REPORTER STATES SHE WEARS THE DEVICE EVERY DAY, AS INSTRUCTED, BUT HAS BEEN HAVING PROBLEMS. REPORTER STATES THE INCLUDED ELECTRODES CAUSE HER SKIN TO ITCH AND THEY ARE "TOO ADHESIVE" AND CAUSE CONSTANT SKIN IRRITATION. REPORTER STATES THERE WAS ALSO A PROBLEM WITH THE BATTERY THAT WAS ONLY RECENTLY

  Patient problems: Itching Sensation; Skin Inflammation/ Irritation

  MAUDE report 19226210 ↗
• InjuryOct 26, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED IRRITATION AND A RASH AFTER 2 DAYS OF TREATING WITH THE 63B ELECTRODES. THE PATIENT FURTHER ADVISED THAT SHE DID NOT CONDUCT THE TIME TEST WHEN CHANGING TO THE 63B ELECTRODES. THE CUSTOMER SERVICE REPRESENTATIVE ADVISED TO CONDUCT THE TIME TEST AND REPORT BACK TO CUSTOMER SERVICE IF THERE ARE ANY ISSUES. THE PATIENT STATED THE 63B ELECTRODES ALSO CAUSED A RASH. THE PATIENT SAW THE DOCTOR AND WAS PRESCRIBED A CREAM FOR THE IRRITATION. THE DOCTOR TOLD HER TO CALL ZIMVIE. THE PATIENT STATED SHE TOLD THE DOCTOR SHE WAS GOING TO LET HER SKIN HEAL AND TRY AGAIN. THE PATIENT STATED SHE WORE 63B ELECTRODES FOR ONE HOUR THE FIRST DAY AND TWO HOURS THE NEXT DAY. THE PATIENT STATED HER SKIN IMMEDIATELY WAS IRRITATED. THE PATIENT WAS ADVISED BY A ZIMVIE CUSTOMER SERVICE REPRESENTATIVE TO STOP WEARING THE ELECTRODES UNTIL HER SKIN COMPLETELY HEALED. THE 63B ELECTRODES WERE NOT RETURNED FOR EVALUATION.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 18015733 ↗
• InjuryJul 22, 2023Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT THE THE 63B ELECTRODES IRRITATED HER SKIN. THE PATIENT DID NOT DO THE TIME TEST WHEN SHE SWITCHED THE ELECTRODES. PATIENT TREATS 12 HOURS AND RESTS THE SKIN FOR 12 HOURS. THE PATIENT STATED SHE WASHES HER SKIN WITH WARM WATER AND USES HYDROCORTISONE CREAM IN BETWEEN. THE PATIENT NEVER SPOKE WITH HER DOCTOR ABOUT THE IRRITATION BECAUSE SHE HAS ALWAYS HAD SENSITIVE SKIN. THE PATIENT'S SKIN WAS RED, ITCHY AND HAD BLISTERS. THE PATIENT WOULD LIKE TO GO BACK TO 72R ELECTRODES AS THE IRRITATION WAS NOT AS BAD AS WITH THOSE. THE PATIENT WILL PERFORM THE TIMED TEST FOR 2 DAYS AT EACH STAGE AND REPORT BACK IF THERE ARE ANY ISSUES. THE 72R ELECTRODES WERE SHIPPED TO THE PATIENT. IT WAS LATER REPORTED BY THE PATIENT THAT EVERY SINGLE ELECTRODE THAT SHE HAS USED HAS CAUSED SKIN IRRITATION. THE PATIENT SPOKE TO HER DOCTOR AND WAS TOLD TO DISCONTINUE USING THE ELECTRODES. THE DOCTOR DID NOT PRESCRIBE ANYTHING. THE PATIENT WAS USING HYDROCORTISONE OVER THE COUNTER. THE ONLY THING THAT HELPED THE PATIENT WAS NOT USING THE ELECTRODES. THE PATIENT USED THE UNIT FOR AS LONG AS POSSIBLE. THE PATIENT HAD RED AND ITCHINESS, A RASH, SIGNIFICANT CONTACT DERMATITIS, AND

  Patient problems: Blister; Itching Sensation; Skin Inflammation/ Irritation

  MAUDE report 17375403 ↗
• InjuryJul 19, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED BY THE PATIENT THAT THE 72R ELECTRODES CAUSED AN IRRITATION ON HER SKIN. THE PATIENT WORE THE ELECTRODES FOR 2-3 DAYS. THE PATIENT CALLED THE DOCTOR AND WAS TOLD TO CALL (B)(6) . THE PATIENT STATED THAT THE IRRITATION HAS GOTTEN BETTER SINCE CHANGING THEM EVERY DAY. THE PATIENT WAS ADVISED TO STOP WEARING THE ELECTRODES AND TO LET HER SKIN HEAL AND TRY THE 63B ELECTRODES. 63B ELECTRODES HAVE BEEN SENT TO THE PATIENT. THERE IS NO PRODUCT TO RETURN. IT WAS REPORTED BY THE PATIENT THAT THE 63B ELECTRODES ARE ALSO IRRITATING HER SKIN AS WELL. THE PATIENT STATED THAT SHE DID NOT DO THE TIME TEST WHEN SHE SWITCHED ELECTRODES. THE PATIENT STATED THAT SHE TREATS FOR 12 HOURS AND RESTS THE SKIN FOR 12 HOURS. THE PATIENT WASHES THE SKIN WITH WARM WATER AND USES HYDROCORTISONE CREAM IN BETWEEN. THE PATIENT DID NOT SPEAK TO HER DOCTOR ABOUT THE IRRITATION BECAUSE SHE HAS ALWAYS HAD SENSITIVE SKIN. THE PATIENT'S SKIN WAS RED, ITCHY AND HAD BLISTERS. THE PATIENT WANTS TO GO BACK TO USING THE 72R ELECTRODES AS THE IRRITATION WASN'T AS BAD WITH THEM. THE PATIENT WILL PERFORM THE TIME TEST FOR 2 DAYS AT EACH STAGE AND REPORT BACK IF THERE ARE ANY ISSUES. THE 72R ELECTRODES AND USPS

  Patient problems: Blister; Skin Inflammation/ Irritation

  MAUDE report 17351632 ↗
• InjuryJun 15, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT HAD MORE IRRITATION AFTER USING THE 63B ELECTRODES. SHE IS HAVING TO DISCONTINUE THE USE OF THE DEVICE PER HER DERMATOLOGIST. IF HER SPINE SURGEON DETERMINES SHE NEEDS TO RESTART THE USE OF THE DEVICE AFTER HER JULY APPOINTMENT, SHE WILL USE THE 72R ELECTRODES FOR A FEW HOURS A DAY. THE PATIENT EXPLAINED THE SEVERITY OF THE IRRITATION WITH THE 63B ELECTRODES. THE IRRITATION BEGAN DURING THE FIRST WEEK WITH THE 63B ELECTRODES. HER SKIN WAS ITCHY FOR ABOUT ONE WEEK THEN HER IRRITATION SPREAD ALL OVER HER BACK AND SHE HAD BUMPS AND WHITE BUMPS ON HER BACK. SHE SAW HER DERMATOLOGIST WHO DIAGNOSED HER WITH IRRITANT CONTACT DERMATITIS, PRESCRIBED CLOBETASOL PROPIONATE 0.05 CREAM, AND ASKED HER TO DISCONTINUE THE USE OF THE ELECTRODES. I ASKED THE PATIENT WHEN SHE TRANSITIONED TO THE 63B ELECTRODES IF SHE COMPLETED THE TIME TEST. THE PATIENT SAID SHE DID NOT PERFORM THE TIME TEST WITH 63B ELECTRODES. WHEN SHE USED THE 63B ELECTRODES THE PATIENT CLAIMS SHE CHANGED TO NEW ELECTRODES EVERY 2-3 DAYS AND ROTATED AT THAT TIME. THE PATIENT CLEANED HER SKIN IN THE SHOWER. THE PATIENT IS ALLERGIC TO PENICILLIN, ALEVE, VIOXX, CEVANES AND GABAPENTIN, COMBI PATCHES. T

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 17139585 ↗
• InjuryMay 18, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT HAD A SIMILAR IRRITATION TO THE 63B ELECTRODES. THE CUSTOMER SERVICE REPRESENTATIVE SPOKE WITH THE PATIENT, AND SHE ADVISED THE 63B ELECTRODES GAVE HER A SIMILAR SKIN IRRITATION. SHE SPOKE WITH THE DOCTOR WHO ADVISED THE PATIENT THAT SHE SHOULD DISCONTINUE HER TREATMENT. A RETURN LABEL WAS SHIPPED TO THE PATIENT FOR DEVICE RETURN AND THE APPROPRIATE MANAGERS AND DEPARTMENTS WERE NOTIFIED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 16956626 ↗
• InjuryMay 11, 2023Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT SOMETIMES SHE GETS AN ALLERGIC REACTION WHEN SHE IS UNDER THE SUN FOR TOO LONG. THE PATIENT HAD A SKIN IRRITATION DURING THE TIME TEST AFTER 5 HOURS. THE PATIENT WILL START USING THE 63B ELECTRODES IN 4-HOUR INTERVALS WITH NO COVER PATCHES.63B ELECTRODES HAVE BEEN SENT TO THE PATIENT. THE PRODUCT IS NOT EXPECTED TO BE RETURNED. THE PATIENT CONTACTED HER AND STATED THAT SHE BEGAN USING THE DEVICE FOR 5 CONSECUTIVE HOURS AND SHE HAD A RASH, SHE VISITED HER PRIMARY CARE PHYSICIAN AND WAS PRESCRIBED ATARAX 25 MG SO SHE USED IT THIS TIME AND AS PER EVA THE AREA IS NOW HEALED. NO FURTHER CONSEQUENCES WERE REPORTED. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED. 63B ELECTRODES WERE NOT RETURNED FOR FURTHER EVALUATIONS.

  Patient problems: Hypersensitivity/Allergic reaction; Skin Inflammation/ Irritation

  MAUDE report 16911119 ↗
• InjuryMar 10, 2023Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS HAVING IRRITATION FROM THE 63B ELECTRODES. THE PATIENT WHO THAT HE DID NOT CONDUCT THE TIME TEST FOR THE 63B ELECTRODES. THE PATIENT STATED THAT HE WORE THE ELECTRODES FOR 3 HOURS THEN STARTED WEARING THEM FOR A FULL DAY. THE NEUROSURGEON TOLD HIM TO STOP WEARING THE UNIT. THE PATIENT JUST HAD SPINE STIM REMOVED YESTERDAY. THE PATIENT GOES BACK TO HIS DOCTOR ON 02/27. THE PATIENT STATED THAT HE IS GOING TO LET HIS SKIN HEAL UP FIRST WHICH MAY TAKE A FEW WEEKS AND THEN WILL TRY WEARING THE ELECTRODES FOR ONE HOUR EACH DAY TO SEE IF THAT HELPS. THE PATIENT WILL ALSO SPEAK TO THE DOCTOR AT THE NEXT APPOINTMENT TO SEE IF THE DOCTOR WANTS HIM TO KEEP WEARING THE UNIT OR NOT. THE PATIENT STATED THAT HE HASN'T WORN THE UNIT SINCE THE IRRITATION AND THE 63BS CAUSED THE SAME PROBLEM THE 72RS DID. THE PATIENT HASN'T USED ANY CREAMS OR OINTMENTS. NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 16521637 ↗
• InjuryMar 9, 2023Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  HOLD RH 3.14.23 TITLE: COMPARISON OF PATIENT-REPORTED OUTCOMES AFTER PENILE PROSTHESIS PLACEMENT IN MEN WITH AND WITHOUT PEYRONIE'S DISEASE. WE EVALUATED OUTCOMES IN PATIENTS UNDERGOING PENILE PROTHESIS (PP) IMPLANTATION FOR ERECTILE DYSFUNCTION (ED) AND CONCURRENT PEYRONIE¿S DISEASE (PD). A CLINICIAN-DEVELOPED SURVEY TO ASSESS SATISFACTION WAS SENT TO 354 PATIENTS WHO UNDERWENT PP PLACEMENT FROM 2012¿2018 BY A SINGLE-SURGEON. RESULTS WERE COMPARED BASED ON THE PRESENCE OR ABSENCE OF CONCURRENT PD. 79 PATIENTS COMPLETED THE SURVEY (RESPONSE RATE 22%), INCLUDING 38 PATIENTS (48%) WITH CONCURRENT ED AND PD (ED/PD). MEAN FOLLOW-UP WAS 31 MONTHS (STANDARD DEVIATION 19). 87% FELT THEIR CONDITION WAS ¿VERY MUCH¿ OR ¿MUCH¿ IMPROVED. THERE WAS NO SIGNIFICANT DIFFERENCE IN PATIENT-REPORTED OVERALL SATISFACTION WITH THEIR PP OR SATISFACTION WITH CURRENT PENILE LENGTH/GIRTH BASED ON THE PRESENCE OR ABSENCE OF PD. 87% OF PATIENTS WITH PD WERE SATISFIED WITH THEIR DEGREE OF PENILE STRAIGHTENING AFTER PP PLUS OR MINUS CONCURRENT STRAIGHTENING MANEUVERS SUCH AS MODELING, PLICATION, OR INCISION/GRAFTING. SUB-GROUP ANALYSES WERE PERFORMED TO EVALUATE OUTCOMES IN THOSE WITH CONCURRENT PD/ED WHO REQU

  Patient problems: Blister; Rash; Skin Inflammation/ Irritation

  MAUDE report 16516299 ↗
• InjuryMar 7, 2023Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THAT THE 63B ELECTRODES IRRITATED HER SKIN, THE SKIN WAS RED AND ITCHY. THE PATIENT DID NOT DO THE TIME TEST AND STATED THAT SHE SPOKE TO HER DOCTOR AND THAT THE DOCTOR TOLD HER TO DISCONTINUE THE USE OF THE BONE GROWTH STIMULATOR.

  Patient problems: Itching Sensation; Skin Inflammation/ Irritation

  MAUDE report 16499335 ↗
• InjuryNov 23, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED BY THE PATIENT THAT HE RETURNED THE ELECTRODES AND COVER PATCHES ON (B)(6) 2022, THE PATIENT STATED THAT ALL THE ELECTRODES HE TRIED HAVE CAUSED A SKIN IRRITATION. NOW HE IS GETTING BLISTERS WITHIN AN HOUR. THE DOCTOR TOLD THE PATIENT TO STOP USING THE STIMULATOR FOR A MONTH. THE DOCTOR JUST TOLD THE PATIENT TO USE ALOE VERA. AFTER THE MONTH IS UP THE PATIENT WILL START DOING THE TIME TEST WITH 63B ELECTRODES. THE PATIENT STATED THAT HE IS TIRED OF GETTING THE SKIN IRRITATION AND HE IS THANKFUL, BUT HE KNOWS THAT HE WILL GET A REACTION WITHIN 1 OR 2 HOURS.

  Patient problems: Blister; Skin Inflammation/ Irritation

  MAUDE report 15851310 ↗
• InjuryNov 4, 2022Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT SHE EXPERIENCED IRRITATION TO THE 63B ELECTRODES. ACCORDING TO THE PATIENT, SHE WAITED UNTIL SKIN WAS CLEAR BEFORE TRYING THE 63B ELECTRODES. THE PATIENT REPORTED THAT SHE PERFORMED THE TIME TEST WITH THE 63B ELECTRODES AND SUCCESSFULLY TREATED FOR 3 DAYS AND 1 TO 2 HOURS PER DAY. THE PATIENT STATED THAT THE IRRITATION BEGAN WHILE TREATING FOR 3 HOURS. THE PATIENT DESCRIBES THE SKIN AS RED AND ITCHY WITH BLISTERS AND WELTS. SHE CHANGED AND ROTATED THE ELECTRODES DAILY. THE PATIENT STATED THAT THE IRRITATION WAS DIRECTLY UNDER THE ELECTRODES. THE PATIENT STATED THAT SHE CLEANED THE AREA WITH DOVE SOAP, AND SHE DOES NOT HAVE SENSITIVE SKIN. THE PATIENT REPORTED THAT SHE IS ALLERGIC TO PLAVIX AND SULFA DRUGS BUT HAS NO SEASONAL ALLERGIES. THE PATIENT STATED THAT SHE DOES NOT TAKE BLOOD PRESSURE MEDICATION BUT DOES TAKE A BETA BLOCKER FOR IRREGULAR HEARTBEAT. THE PATIENT DID NOT SPEAK TO A DOCTOR ABOUT IRRITATION BUT HAS A FOLLOW UP APPOINTMENT WITH HER SURGEON IN (B)(6) OF 2022 AND WILL DISCUSS IT THEN. THE PATIENT WILL KEEP 63B ELECTRODES LOT # 132301 AND WILL CONTINUE USE FOR 2 HOURS PER DAY. IT WAS LATER REPORTED BY THE PATIENT THAT SHE SPOKE TO

  Patient problems: Blister; Itching Sensation; Skin Inflammation/ Irritation

  MAUDE report 15726932 ↗
• InjuryOct 27, 2022Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT HER SKIN BECAME IRRITATED WHILE USING THE 62B ELECTRODES. THE PATIENT STATED THAT SHE DID NOT DO THE TIME TEST AND USED THE SAME ELECTRODES FOR 2 DAYS IN A ROW. THE PATIENT WOULD TAKE THE ELECTRODES OFF AND PUT THE SAME ONES BACK ON. OUR CUSTOMER SERVICE REPRESENTATIVE ADVISED THE PATIENT TO WAIT UNTIL HER SKIN WAS COMPLETELY HEALED THEN CONDUCT A TIME TEST AT 1-HOUR INCREMENTS STARTING WITH THE 63B ELECTRODES. THEY ALSO DISCUSSED CHANGING THE ELECTRODES EACH DAY AND CHANGING THE POSITION OF HER SKIN. THE PATIENT WAS ADVISED TO CALL BACK IF THERE ARE ANY ISSUES DURING THE TIME TEST. THE PATIENT STATED THAT SHE STOPPED USING THE PRODUCT ON HER OWN BECAUSE OF THE ALLERGIC REACTION TO THE ELECTRODES. THE PATIENT MADE HER DOCTOR AWARE THAT SHE STOPPED USING THE PRODUCT. THE DOCTOR DID NOT PRESCRIBE ANY MEDICATION TO HER. THE PATIENT STATED THAT SHE WILL TALK TO HER DOCTOR AGAIN AND MIGHT TRY TREATMENT AGAIN STARTING WITH 30-MINUTE INCREMENTS. THE PATIENT WILL RETURN AN EXAMPLE OF THE 63B ELECTRODES AND WILL FOLLOW UP WITH THEM NEXT WEEK. THE PATIENT STATED THAT SHE WENT TO THE EMERGENCY ROOM LAST WEEK FOR AN UNRELATED ISSUE AND USED THE ELECTRODES WH

  Patient problems: Hypersensitivity/Allergic reaction; Skin Inflammation/ Irritation

  MAUDE report 15685591 ↗
• InjuryOct 18, 2022Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE 63B ELECTRODE GLUE IS MAKING THE PATIENT'S SKIN BREAK OUT. SHE WAS ADVISED TO TAKE A BREAK UNTIL HER SKIN CLEARS UP. THE PATIENT STATED SHE WORE 63B ELECTRODE 24/7 THEN CUT DOWN TO 12 HOURS. THE NURSE RECOMMENDED CORTISONE CREAM. THE PATIENT DID NOT SPEAK TO HER DOCTOR. SHE DID NOT ROTATE THE COVERS DID ROTATE. THE PATIENT HAS AN ALLERGY TO LATEX AND HAS SENSITIVE SKIN. THE PATIENT WILL WAIT FOR HER SKIN TO HEAL THEN TRY A COUPLE OF HOURS FOR A WEEK AND SEE IF THAT WORKS. SHE IS ALSO GOING TO TRY AND REMOVE THE GLUE OFF OF THE ELECTRODES AND PUT THE COVERS OVER THEM TO KEEP THEM IN PLACE AND SEE IF THAT WORKS. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Rash; Skin Inflammation/ Irritation

  MAUDE report 15628859 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P850022. One submission often covers many models, so check the product and lot details in each record.

• Z-1618-2024 · Mar 22, 2024 · Open, Classified
  20" Lead Wires, Replacement Part Number: 1067724-2
• Z-1617-2024 · Mar 22, 2024 · Open, Classified
  Biomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bon
• Z-1616-2024 · Mar 22, 2024 · Open, Classified
  Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat
• Z-1619-2024 · Mar 22, 2024 · Open, Classified
  48" Lead Wires, Replacement Part Number: 1067724-4