Biomet SpinalPak / OrthoPak 106130-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 188 adverse event reports that list this exact device (DI 00812301020201), received between May 10, 2019 and Jun 5, 2026 — classified as 1 death, 186 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (162 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 188 reports, in the reporter's own words as published by the FDA.

• InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem

  THE SALES REP REPORTED THAT THE PATIENT EXPERIENCED A BURNING PAIN IN HER BUTTOCKS AFTER SLEEPING WITH THE DEVICE LAST WEEKEND. THE CUSTOMER SERVICE REPRESENTATIVE CALLED THE PATIENT AND FOUND THAT THE PADS HAD BURNED HER ON HER BACK. THE PATIENT STATED SHE HAD PAIN IN HER BUTTOCKS. THE 72R ELECTRODES WERE CLOSE TO EACH OTHER, 3 INCHES APART. THE PATIENT STATED SHE HAS 2 RED MARKS ON HER BACK. SHE HAD THE ELECTRODES ON FOR 2 OR 3 DAYS WHEN SHE GOT THE BURN ON MAY 1ST. THE PATIENT STATED SHE HAS PAIN ON HER BUTTOCKS. THE PATIENT WENT TO HER PCP TODAY AND GOT AN INJECTION FOR THE PAIN. THE PATIENT STATED THE PAIN HAS GONE AWAY. THE PATIENT DID NOT CALL THE SURGEON. THE PATIENT HAS INCREASED HER DAILY ACTIVITIES. HER FOOT STARTED SWELLING. THE PAIN LEVEL FROM THE BURN WAS A 10. THE PATIENT ASKED HER HUSBAND TO TAKE THE ELECTRODES OFF. THE PAIN IN THE BUTTOCKS WAS A 10 AS WELL. THE PATIENT STATED THAT SHE DID NOT HAVE THIS PAIN BEFORE. THE PATIENT CANNOT SLEEP BECAUSE OF THE PAIN. THE PATIENT DOES NOT WANT TO CONTINUE TREATMENT. NO FURTHER CONSEQUENCES WERE REPORTED.

  Patient problems: Burn(s); Pain; Swelling/ Edema

  MAUDE report 25414862 ↗
• InjuryMay 11, 2026Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT STARTED HAVING SYSTEMIC ALLERGIC REACTIONS SINCE HER SURGERY. THE PATIENT WORE THE 72R ELECTRODES 24/7 AND CHANGED THEM EVERY NIGHT. THE PATIENT REPORTED BREAKING OUT IN LITTLE BUMPS WHICH WERE ALL OVER THE BODY. THE PATIENT WENT TO URGENT CARE AND WAS GIVEN PREDNISONE AND TOPICAL CREAM. THIS DID NOT WORK. THE PATIENT ADVISED THAT THEY WOULD GO TO AN ALLERGIST SOON TO DETERMINE WHAT IS CAUSING THE ISSUE. THE PATIENT WAS SHIPPED ALTERNATE ELECTRODES TO TRY AND WILL CONDUCT A TIMED TEST. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 25142864 ↗
• InjuryMar 23, 2026Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS LATER REPORTED THAT THE PATIENT CONTINUED TO HAVE SKIN IRRITATION. THE PATIENT SPOKE WITH THE PRESCRIBING DOCTOR AND A DERMATOLOGIST WHO SAID THAT NOT ONLY ARE THE 72R 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 STATED THAT THE ELECTRODES CAUSED A RASH AND SEEMED TO BURN HER 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¿S DOCTOR ULTIMATELY DECIDED TO PRESCRIBE AN ALTERNATIVE DEVICE DUE TO THE PATIENT¿S ONGOING SKIN IRRI

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

  MAUDE report 24660835 ↗
• InjuryMar 20, 2026Patient-Device Incompatibility

  THE PATIENT ADVISED THAT THE 72R ELECTRODES ARE CAUSING A SKIN IRRITATION IN THE CERVICAL AREA. THE SKIN IRRITATION STARTED A COUPLE OF MONTHS AGO. THE SKIN IS RED, ITCHY, CAUSING BLISTERS AND WELTS. THE ELECTRODES AND COVER PATCHES ARE CHANGED AND MOVED AROUND EVERY DAY. THE AREA IS CLEANED WITH SOAP AND WATER, NO WIPES. THE PATIENT IS USING OPZELURA CREAM PRESCRIBED BY HIS DERMATOLOGIST FOR THE IRRITATION IN THE CERVICAL AREA. THE PATIENT DID GO SEE THE DERMATOLOGIST FOR THIS ISSUE, THE SURGEON WAS NOT AWARE OF THE IRRITATION. THE PATIENT ADVISED THE SALES REP THAT 72R ELECTRODES ARE NOT STICKING AND CAUSING A MINOR IRRITATION, BUT NO ADVICE WAS GIVEN. THE PATIENT HAS NO KNOWN ALLERGIES, THE PATIENT HAS SEASONAL ALLERGIES. 63B ELECTRODES AND COVER PATCHES WERE SHIPPED TO THE PATIENT.

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

  MAUDE report 24650165 ↗
• InjuryFeb 13, 2026Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SKIN IRRITATION WITH THE 72R ELECTRODES. THE SKIN IRRITATION WAS ON THE LUMBAR AREA. THE PATIENT STATED THAT THE SKIN IS RED AROUND THE EDGE AND IT GETS ITCHY BY THE END OF THE DAY. THE PATIENT CHANGES THE ELECTRODES ONCE PER WEEK BUT REMOVES THEM EVERY NIGHT. THE ELECTRODES ARE NOT MOVED AROUND TO DIFFERENT LOCATIONS. THE IRRITATED AREA WAS CLEANED WITH AN ALCOHOL PAD. THE PATIENT APPLIED BENADRYL CREAM FOR THE ITCHING. THE PATIENT WAS SHIPPED ALTERNATE ELECTRODES TO TRY. IT WAS LATER REPORTED THAT THE PATIENT¿S DOCTOR ADVISED HER TO DISCONTINUE TREATMENT AT A FOLLOW UP APPOINTMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Itching Sensation; Skin Inflammation/ Irritation

  MAUDE report 24332726 ↗
• InjuryJan 26, 2026Patient-Device Incompatibility

  IT WAS REPORTED BY THE SALES REPRESENTATIVE (B)(6) THAT THE PATIENT HAD A SKIN IRRITATION WITH 72R ELECTRODES. THE CUSTOMER SERVICE REPRESENTATIVE CALLED THE PATIENT TO COLLECT DETAILS AND HAD TO LEAVE A VOICEMAIL FOR A RETURN CALL. THE PATIENT CALLED BACK AND ADVISED THE IRRITATION STARTED WEEKS AGO ON (B)(6) 2025. THE PATIENT SAW HER DOCTOR REGARDING THE IRRITATION AND THE DOCTOR TOLD HER TO REDUCE THE TIME TO 30 MINUTES AND THEN GRADUALLY INCREASE THE TIME. BY THIS TIME THE PATIENT HAS STOPPED USING THE SPAK AFTER FOLLOWING THE DOCTOR'S INSTRUCTIONS THE ITCHING AND REDNESS WAS TOO MUCH. AND SHE COULD NOT DO IT. THE PATIENT CLEANS THE AREA WITH ALCOHOL AND TRIED AGAIN. THE PATIENT STARTED ITCHING WITHIN AN HOUR. THE PATIENT HAS SENSITIVE SKIN. THE ELECTRODES WERE USED AT LEAST 3 OR 4 TIMES BEFORE CHANGING THEM. THE PATIENT REMOVED THE ELECTRODES WHEN SHE TOOK A SHOWER. THE SKIN WAS RED AND ITCHY. NO WELTS OR BLISTERS. THE AREA WAS CLEANED WITH SOAP AND WATER ONE DAY SHE USED ALCOHOL. THE PATIENT DID NOT APPLY ANYTHING ON THE AREA. THE PATIENT HAS FOOD ALLERGIES AND SEASONAL ALLERGIES. A PCP PRESCRIBED A CREAM. THE PATIENT WAS NOT HOME TO OFFER THE NAME OF THE CREAM. THE PATIENT W

  Patient problems: Itching Sensation; Skin Inflammation/ Irritation

  MAUDE report 24183765 ↗
• InjuryJan 8, 2026Patient-Device Incompatibility

  UPDATE ON 15DEC2025: SECOND ATTEMPT MADE BY PHONE FOR ADDITIONAL INFORMATION AND TO CONFIRM MEDICAL INTERVENTION. PATIENT ADVISED THAT SHE ALSO EXPERIENCED SKIN IRRITATION WITH THE 63B ELECTRODES. SHE ALLOWED THE IRRITATION WITH THE 72R ELECTRODES TO RESOLVE COMPLETELY BEFORE TRYING THE 63B ELECTRODES. SHE STARTED OFF WITH ONE HOUR AND WAS ABLE TO GET TO THREE HOURS OF TREATMENT BEFORE EXPERIENCING THE IRRITATION. THE AREA BECAME RAISED AND VERY ITCHY. PATIENT STATED THAT THE IRRITATION IS THE SAME AS WITH THE 72R ELECTRODES, SHE DID NOT NOTICE ONE BEING WORSE THAN THE OTHER. THE PATIENT HAS NOT DISCUSSED THE IRRITATION WITH THE 63B ELECTRODES WITH THEIR DOCTOR. PATIENT ADVISED THAT THE DOCTOR RECOMMENDED USING HYDROCORTISONE CREAM AND ANOTHER OINTMENT SHE COULD NOT RECALL FOR THE SKIN IRRITATION WITH THE 72R ELECTRODES. PSS BRIANNE MCGILL ADVISED THE PATIENT THAT WE DO NOT HAVE ANOTHER TYPE OF ELECTRODE. ADVISED THE PATIENT TO DISCUSS WITH SALES REP AND/OR DOCTOR FOR NEXT STEPS. PATIENT WILL RETURN A SAMPLE OF THE 72R ELECTRODES. PATIENT STATED THAT THE SKIN IRRITATION STARTED LAS WEEK ON THE CERVICAL AREA. THE SKIN IS VERY ITCHY WITH WELTS. THE DOCTOR'S OFFICE TOLD HER THIS MORNI

  Patient problems: Itching Sensation; Skin Inflammation/ Irritation

  MAUDE report 24003254 ↗
• InjuryNov 17, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT WAS DISCONTINUING USE OF THE ORTHOPAK AND SWITCHING TO THE BONE HEALING SYSTEM (BHS) DUE TO SKIN IRRITATION WITH THE ELECTRODES. THE PATIENT WORE THE 72R ELECTRODES FOR 10 TO 15 HOURS PER DAY. THE ELECTRODES WERE CHANGED DAILY, AND THE PATIENT ALSO WORE THE COVER PATCHES. THE RASH WAS ALL OVER THE PATIENT¿S BODY. THE PATIENT TOOK BENADRYL IN ADDITION TO MEDICATION FOR DIABETES AND HIGH BLOOD PRESSURE. THE PATIENT ADVISED THEIR DOCTOR OF THE SKIN IRRITATION AT A FOLLOW-UP VISIT AND THE DOCTOR RECOMMENDED SWITCHING TO THE BHS. NO FURTHER CONSEQUENCES ARE REPORTED. THE PRODUCT WAS RETURNED FOR FURTHER EVALUATION.

  Patient problems: Rash; Skin Inflammation/ Irritation

  MAUDE report 23568814 ↗
• InjuryOct 27, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE PATIENT REPORTED GETTING ELECTRIC SHOCKS FROM THE UNIT. THE PATIENT USED THE UNITS 3 TIMES. THE PATIENT STATED THAT WHEN SHE TOOK OFF THE UNIT, SHE FELT ELECTRIC SHOCKS AFTER WEARING IT FOR 4 HOURS. PATIENT STATED THE PAIN LEVEL WAS 15 OUT OF 10. ON THE FIRST DAY THE PATIENT HAD HEADACHES AND NAUSEA AFTER USING THE UNIT FOR ONE HOUR. ON THE THIRD DAY THE PATIENT WORE THE UNIT FOR ABOUT 8 HOURS. THE PATIENT STATED THAT SHE HAS NOT EXPERIENCED ANY FEELINGS LIKE THAT SINCE SHE STOPPED USING THE UNIT. A REPLACEMENT CONTROLLER AND ELECTRODES WERE SHIPPED TO THE PATIENT. NO FURTHER CONSEQUENCES ARE REPORTED. THE PRODUCT WAS RETURNED FOR FURTHER EVALUATION.

  Patient problems: Pain

  MAUDE report 23391515 ↗
• InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT THE 72R ELECTRODES CAUSED A SKIN IRRITATION. IT WAS A RASH THAT WAS RED WITH BLISTERS AND WAS VERY ITCHY. THE PATIENT USED BENADRYL AND HYDROCORTISONE CREAM TO APPLY OVER THE AFFECTED AREA. THE PATIENT WAS NOT SURE IF THIS HAD BEEN PRESCRIBED PREVIOUSLY. THE PATIENT STATED HE IS NOT SURE IF HIS WIFE CONTACTED THE DOCTOR REGARDING THE SKIN IRRITATION. THE PATIENT WILL START USING THE 63B ELECTRODES ONCE THEIR SKIN HAS HEALED FROM THE RASH. NO FURTHER CONSEQUENCES ARE REPORTED. THERE WAS NO PRODUCT RETURNED FOR FURTHER EVALUATION.

  Patient problems: Blister; Rash; Skin Inflammation/ Irritation

  MAUDE report 23351924 ↗
• InjurySep 30, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER PATIENT PHONE CALL: THE PATIENT TREATED FOR A FEW WEEKS UNTIL LATE MAY WHILE SHE HAD IRRITATION FROM THE ELECTRODES. THE SKIN WAS RED AND ITCHY AND SHE HAD A RASH. SHE USED CORTISONE PRESCRIPTION FROM HER PCP DOCTOR. THAT DID NOT HELP S SHE USED CALAMINE PINK LOTION AND THAT HELPED HER SKIN. THEN SHE TRIED TREATING AGAIN FOR 3 DAYS AND THE IRRITATION HAPPENED AGAIN SO SHE STOPPED TREATING IN MAY. THEN AT HER FOLLOW UP APPOINTMENT WITH HER ORTHOPEDIST SHE TOLD HIM SHE WASN'T USING THE UNIT ANY LONGER BECAUSE OF THE IRRITATION. HE TOLD HER SHE WAS NOT HEALING AND SHE NEEDED TO TREAT AND TO CALL EBI FOR ELECTRODE SUGGESTIONS. THE PATIENT WILL PERFORM THE TIME TEST WITH THE 63B ELECTRODES AND CALL CS BACK IF THERE ARE ANY ISSUES. THE PATIENT WILL RETURN ONE EXAMPLE OF THE 72R ELECTRODES WITH THE POUCH PROVIDED.

  Patient problems: Hypersensitivity/Allergic reaction; Peritoneal Laceration(s); Skin Inflammation/ Irritation

  MAUDE report 23185751 ↗
• InjurySep 17, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE PATIENT WAS HAVING REALLY BAD REACTION TO THE ELECTRODES, BREAKING OUT IN A RASH AND PAINFUL HIVES. A NEW REPLACEMENT 63B ELECTRODES WERE SENT TO THE PATIENT. NO FURTHER CONSEQUENCES WERE REPORTED. 72R ELECTRODES HAS NOT BEEN RETURNED FOR EVALUATION.

  Patient problems: Blister; Pain; Skin Inflammation/ Irritation

  MAUDE report 23072521 ↗
• InjurySep 17, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED BY THE PATIENT THAT THE 72R ELECTRODES IRRITATE THE SKIN. THE SKIN WAS RED AND HAD BLISTERS WHILE SHE WAS IN REHAB CARE FACILITY. THE PATIENT COULD NOT ASSIGN A LEVEL OF PAIN TO THIS DISCOMFORT. THE PATIENT SPOKE WITH HER DOCTOR AND WAS GIVEN AN ANTISEPTIC SOAP TO USE ON THE AREA AND THE DOCTOR ADVISE THE PATIENT TO PAUSE HER TREATMENT. THE PATIENT WAS TOLD TO USE THE SOAP UNTIL HER SKIN IS CLEAR. THE PATIENT WAS TO CONTINUE TREATING ONCE HER SKIN WAS CLEARED. THE PATIENT CLAIMED SHE DID NOT CONTINUE TREATING AND DID NOT TELL HER DOCTOR. NO FURTHER CONSEQUENCES WERE REPORTED. 72R ELECTRODES HAS NOT BEEN RETURNED FOR EVALUATION.

  Patient problems: Rash; Skin Inflammation/ Irritation

  MAUDE report 23072336 ↗
• InjurySep 2, 2025Patient-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 THE 72R ELECTRODE CAUSED SKIN IRRITATION. THE PATIENT WENT TO THE SURGEON REGARDING THE SKIN IRRITATION AND WAS PRESCRIBED A CREAM. THE SKIN IRRITATION WAS ITCHY AND THE SKIN FELT RAW. THE PATIENT DOES NOT REMEMBER THE NAME OF THE CREAM. NO FURTHER CONSEQUENCES WERE REPORTED. THE 72R ELECTRODES WERE NOT RETURNED.

  Patient problems: Rash; Skin Inflammation/ Irritation

  MAUDE report 22943766 ↗
• InjuryAug 22, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT DEVELOPED SKIN IRRITATION WHILE USING THE 72R ELECTRODES AND COVER PATCHES. THE PATIENT¿S SKIN WAS RED AND ITCHY WITH RED BUMPS. ON SOME DAYS, THERE ARE HIVES SURROUNDING THE IRRITATED AREA AS WELL. THE PATIENT USES EACH SET OF ELECTRODES FOR APPROXIMATELY ONE WEEK AND USES THE COVER PATCHES FOR THREE DAYS EACH. THE PATIENT WAS UNSURE IF THE IRRITATION WAS FROM THE ELECTRODES, COVER PATCHES, OR BOTH. THE PATIENT SPOKE WITH HER DOCTOR WHO SUGGESTED OVER THE COUNTER HYDROCORTISONE CREAM AND ALLERGY CREAM TO FIGHT THE IRRITATION. THE PATIENT ADDED THAT SHE CANNOT ROTATE THE POSITION OF THE ELECTRODES AND COVER PATCHES BECAUSE THERE IS NOT MUCH ROOM. THE PATIENT WAS ADVISED BY CUSTOMER SERVICE TO ELIMINATE THE COVER PATCHES FROM HER ROUTINE AND PERFORM THE TIME TEST WITH THE ALTERNATE ELECTRODES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Rash; Skin Inflammation/ Irritation

  MAUDE report 22878257 ↗
• InjuryAug 22, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED BY THE PATIENT THAT THE 72R ELECTRODES CAUSED RASH THAT LOOK A LIKE SKIN WAS BURNT. THE PATIENT STATED THAT SHE CHANGED THEM DAILY AND ROTATES THE POSITION ON HER SKIN. THE ELECTRODES WERE PLACED ON HER NECK. THE PATIENT DOES HAVE SENSITIVE SKIN. THE PATIENT SPOKE WITH HER DOCTOR AND HE SUGGESTED SHE USES CREAM ON AREA AND ADVISED PATIENT TO TAKE A BREAK IN TREATMENT UNTIL HER SKIN IS COMPLETELY HEALED THEN CONDUCT A TIME TEST STARTING WITH 63B ELECTRODES. THE CUSTOMER SERVICE REPRESENTATIVE DISCUSSED CHANGING THE ELECTRODES AND POSITION OF ELECTRODES EACH DAY AS WELL AS ADVISED HER TO CALL BACK WITH ANY ISSUES DURING THE TIME TEST. NO FURTHER CONSEQUENCES WERE REPORTED. 72R ELECTRODES WERE NOT RETURNED FOR EVALUATION.

  Patient problems: Rash; Skin Inflammation/ Irritation

  MAUDE report 22878198 ↗
• InjuryAug 13, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT DEVELOPED SKIN IRRITATION ON ONE SIDE OF HER BACK FROM THE 72R ELECTRODES AFTER ABOUT 10 DAYS OF TREATMENT. THE SKIN WAS RED WITH A RASH THAT HAD PUSS AND BLOOD AS IT OOZED. THE PATIENT CHANGED THE ELECTRODES DAILY AND ROTATED THE POSITION. ONLY ONE SECTION OF THE PATIENT¿S BACK WAS IRRITATED, NOT THE OTHER POSITIONS. THE PATIENT HAD A FOLLOW UP VISIT WITH THEIR DOCTOR ON (B)(6) 2025 AND WAS ADVISED THAT THE IRRITATION WAS INFECTED. THE DOCTOR PRESCRIBED AN ORAL ANTIBIOTIC AS THE INFECTION WAS GETTING WORSE AND SLOWLY GROWING LARGER THAN THE SHAPE OF THE ELECTRODE. THE DOCTOR ALSO ADVISED NOT TO PUT ANY CREAM ON THE SKIN. THE DOCTOR ADVISED TO CONTINUE TREATMENT AND AVOID THE IRRITATED SECTION OF THE SKIN. IT WAS LATER REPORTED THAT THE SKIN IRRITATION HAD RESOLVED AS OF (B)(6) 2025. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Purulent Discharge; Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 22792545 ↗
• InjuryJun 26, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED BY THE PATIENT THAT THE 72R ELECTRODES TAKE SOME SKIN OFF WHEN SHE REMOVES THEM. SHE ALSO HAS ISSUES WITH MANY BAND-AIDES AND PRODUCTS USED DURING THE SURGERY. THE PATIENT DOES NOT USE ANY CREAMS ON THE IRRITATED SKIN. SHE ADVISED THAT BECAUSE IT HURTS WHEN REMOVED SHE WEARS EACH SET OF ELECTRODES FOR 4 DAYS, AND HAS 4 LOCATIONS ON HER BACK WHEN SHE ROTATES. THE PATIENT STATED THAT EACH IRRITATED SPOT TAKES ABOUT ONE WEEK TO HEAL. THE PATIENT IS COMFORTABLE WITH THIS ROUTINE BECAUSE SHE HAS DEALT WITH SKIN ISSUES FOR A LONG TIME AND HER FOCUS IS HEALING HER BONES. 63B ELECTRODES WERE SHIPPED TO THE PATIENT. PATIENT WAS ADVISED TO TEST THE 63B ELECTRODES ON HER ARM BEFORE STICKING THEM ON HER BACK. NO FURTHER CONSEQUENCES ARE REPORTED. THERE WAS NO PRODUCT RETURNED FOR FURTHER EVALUATION.

  Patient problems: Rash; Skin Inflammation/ Irritation

  MAUDE report 22338706 ↗
• InjuryJun 24, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE PATIENT EXPERIENCED SKIN IRRITATION FROM THE OPAK ELECTRODES. THE DOCTOR WANTS TO SWITCH THE PATIENT TO BHS UNIT. THE PATIENT WAS GIVEN OPAK ON (B)(6) 2025. THE PATIENT HAS SENSITIVE SKIN. SHE TREATED WITH THE UNIT FOR 2 WEEKS AND HAD RED, ITCHY AND IRRITATED SKIN WITH RAISED BUMPS WITH PUSS WHEN THEY POPPED. SHE USED ONLY 72R ELECTRODES AND TREATED FOR 12 HRS A DAY. CHANGED ELECTRODES DAILY, ROTATED THE POSITION AND WASHED THE SKIN WITH ANTIBACTERIAL SOAP AND TREATED THE IRRITATION WITH HYDROCORTISONE CREAM. THE PATIENT HAD FOLLOW-UP WITH DOCTOR ON WEEK 03 OF TREATMENT AND TOLD HER TO STOP USING THE OPAK AND HE WOULD LIKE TO SWITCH HER RX TO BHS. THE DOCTOR DID NOT PRESCRIBE ANYTHING FOR SKIN IRRITATION.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 22318958 ↗
• InjuryJun 23, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED BY THE PATIENT IN A SURVEY THAT THE UNIT CAUSED BURNS TO THE NECK AFTER USING IT FOR 3 NIGHTS. THE PATIENT ALSO REPORTED IT ALSO MADE THE PATIENT'S NEUROPATHY REALLY BAD. THE PATIENT DISCONTINUED USING THE UNIT. THE CUSTOMER SERVICE REPRESENTATIVE CALLED THE PATIENT AND FOUND HE USED THE UNIT FOR 3 DAYS AND THE ELECTRODES GAVE HIM RED BURN MARKS ON HIS NECK. THERE WERE NO BLISTERS AND NO ITCH. AND ON THAT THIRD NIGHT OF TREATING THE PATIENT ALSO AWOKE FROM SLEEP IN SEVERE NERVE PAIN. THE PATIENT HAS NEUROPATHY. HE FELT LIKE HIS BRAIN WAS FRIED AND HIS HANDS, ARMS, AND SHOULDERS WERE FIRED UP. HE RATED THE LEVEL OF PAIN AN 8 OUT OF 10. THE PATIENT CLAIMS IT TOOK HIM SEVERAL HOURS TO DEESCALATE HIS NERVE PAIN. HE TOOK HIS MEDICATION FOR NEUROPATHY. HE TOOK 2 PREGABALIN. HE DID NOT SEEK MEDICAL ATTENTION AT THAT TIME. HE DISCONTINUED TREATMENT. SEVERAL WEEKS LATER HE HAD A FOLLOW UP VISIT WITH HIS SURGEON AND SHE AGREED THAT SOMEHOW HIS NEUROPATHY WAS AN ISSUE AND SUPPORTED HIS DECISION TO DISCONTINUE TREATING. THE PATIENT ADVISED HE USED A CREAM ON THE SKIN ON HIS NECK AND THE SKIN CLEARED UP IN APPROXIMATELY ONE WEEK. NO PRODUCT WAS SHIPPED. NO RETURN REQUESTED. LATE

  Patient problems: Burn(s); Neuropathy; Pain

  MAUDE report 22311093 ↗
• InjuryJun 10, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE PATIENT INDICATED THE UNIT GAVE HORRIBLE CONSTANT MUSCLE CONTRACTIONS. ADDITIONALLY, THE PATIENT MENTIONED THAT SHE HAS ALWAYS HAD SPASMS ON HER BACK SINCE SURGERY. HOWEVER, SHE SAID WHEN SHE WEARS THE STIMULATOR, IT INCREASES HER SPASMS TIMES 10. THE PATIENT WAS ADVISED TO TRY AND DO A SLOW ROLL OUT WITH THE STIMULATOR AND SLOWLY ADD AN HOUR EACH DAY. NO FURTHER CONSEQUENCES WERE REPORTED. THE 72R ELECTRODES WERE NOT RETURNED.

  Patient problems: Cramp(s) /Muscle Spasm(s)

  MAUDE report 22177279 ↗
• InjuryMay 19, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE PATIENT INDICATED THAT THE ELECTRODES WERE IRRITATING HER SKIN. THE PATIENT STATED THAT SHE CONTACTED THE DOCTOR WHO ADVISED TO DISCONTINUE THE USE OF THE DEVICE. THE PATIENT STARTED TREATING AROUND MID MARCH AND REACHED OUT TO SALES REPRESENTATIVE IN MID APRIL REGARDING TO SKIN IRRITATION. NO FURTHER CONSEQUENCES WERE REPORTED. THE 72R ELECTRODES WERE NOT RETURNED FOR EVALUATION.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 22047094 ↗
• InjuryMar 27, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED BY THE PATIENT THAT HE IS HAVING REACTION TO 72R ELECTRODES AND HAD TO GO TO DERMATOLOGIST. LATER, (B)(6) CALLED THE PATIENT FOR DETAILS HAD TO LEAVE A VOICEMAIL FOR A RETURN CALL. NO FURTHER CONSEQUENCES WERE REPORTED. THE 72R ELECTRODES WERE NOT RETURNED FOR FURTHER EVALUATION.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 21708546 ↗
• InjuryMar 27, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED BY THE PATIENT THAT THERE WAS A SKIN IRRITATION AND BUMPS WHILE USING THE 72R ELECTRODES. THE PATIENT STATED IT STARTED ON THE FIRST DAY SHE USED THE SPINAL PAK. WHEN SHE TAKES THE ELECTRODES OFF, SHE CLEANS THE AREA AND APPLIES CREAM EVERY DAY. THE ELECTRODES ARE CHANGED AND MOVED EVERY DAY. THE PATIENT WOULD LIKE TO TRY 63B ELECTRODES TO SEE WHICH ELECTRODES WORKS BEST FOR HER AND SHE WILL PERFORM THE TIME TEST. A REPLACEMENT SUPPLY OF 63B ELECTRODES WAS SHIPPED TO THE PATIENT'S HOME. LATER, THE PRODUCT SURVEILLANCE SPECIALIST CALLED THE PATIENT AND THE PATIENT INDICATED THAT THEY SPOKE TO THEIR DOCTOR WHO ADVISED TO CONTINUE THE USE OF ELECTRODES AND PRESCRIBED AN OTC CREAM TO APPLY ON THE AREA. THE PATIENT RECEIVED 63B ELECTRODES RECENTLY AND WILL CONDUCT TIME-TEST SOON. NO FURTHER CONSEQUENCES WERE REPORTED. 72R ELECTRODES WERE NOT RETURNED FOR INVESTIGATION.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 21708114 ↗
• InjuryFeb 21, 2025Patient-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 ELECTRODES BURNT THE PATIENT¿S SKIN. THE ELECTRODES FELT HOT ON THE SKIN, AND THE SKIN WAS DISCOLORED WHERE THE ELECTRODES WERE PLACED. THE SKIN FELT IRRITATED. THE SKIN IRRITATION WAS FIRST NOTICED BY THE PATIENT¿S PHYSICAL THERAPIST AS THE ELECTRODES ARE PLACED ON THE BACK OF HER NECK. THE PATIENT DID NOT RECALL IF SHE SPOKE TO HER DOCTOR ABOUT IRRITATION AT THE TIME OF THE INCIDENT. IT WAS LATER REPORTED THAT THE PATIENT SHOWED PICTURES OF THE IRRITATION TO A DOCTOR AT AN URGENT CARE FACILITY ON (B)(6) 2025 AND IT WAS DETERMINED TO BE A BURN. A REPLACEMENT DEVICE AND ELECTRODES WERE SHIPPED TO THE PATIENT. NO FURTHER CONSEQUENCES WERE REPORTED.

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

  MAUDE report 21437480 ↗

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-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
• Z-1618-2024 · Mar 22, 2024 · Open, Classified
  20" Lead Wires, Replacement Part Number: 1067724-2