Biomet SpinalPak / OrthoPak 106130-17Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 00812301020195), received between Nov 1, 2019 and Mar 20, 2026 — classified as 52 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (42 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 52 reports, in the reporter's own words as published by the FDA.

• InjuryMar 20, 2026Patient-Device Incompatibility

  IT WAS REPORTED BY THE PATIENT THAT THEY EXPERIENCED SKIN IRRITATION WHEN USING THE COVER PATCHES. THE PATIENT INITIALLY HAD SKIN IRRITATION FROM THEIR DRESSING. THE COVER PATCHES WERE PLACED ON THE SAME AREA, ALSO CAUSING SKIN IRRITATION. THE PATIENT HAD WELTS AND BLISTERS. THE DOCTOR¿S OFFICE PUT THE PATIENT ON STEROIDS. THE PATIENT WAS ALSO APPLYING HYDROCORTISONE CREAM AND TAKING AN ANTIHISTAMINE. THE PATIENT HAS SENSITIVE SKIN AND IS ALLERGIC TO ADHESIVE, DERMABOND, AND PENICILLIN. THE PATIENT DISCONTINUED USE OF THE COVER PATCHES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blister; Skin Inflammation/ Irritation

  MAUDE report 24649277 ↗
• InjuryJan 6, 2026Patient-Device Incompatibility

  DURING SUPPLY ORDER THE PATIENT MENTIONED THAT AT THE BEGINNING OF TREATMENT SHE TRIED THE COVER PATCHES ON ONE DAY ONLY. WHEN SHE REMOVED THE COVER PATCH FROM HER NECK THE ADHESIVE WAS VERY STICKY, SHE COULD NOT GET THE COVERS OFF SO SHE HAD TO RIP IT OFF QUICKLY LIKE A BAND-AIDE AND THIS WAS VERY PAINFUL AND LEFT A RED BRUISE ON HER SKIN. THE PATIENT ASSESSED THE PAIN AT AN 8 OUT OF 10 AND THE PAIN DID NOT LAST LONG. THE PATIENT DID NOT SPEAK TO HER DOCTOR ABOUT THIS EVENT. SHE CONTINUED TREATING WITHOUT THE COVER PATCHES AND EVERYTHING IS WORKING WELL WITHOUT THEM. THE PATIENT WILL RETURN ONE UNUSED COVER PATCH WITH THE POUCH PROVIDED. NO NEW PRODUCT WAS SHIPPED TO THE PATIENT.

  Patient problems: Bruise/Contusion; Erythema; Pain

  MAUDE report 23983554 ↗
• InjuryOct 15, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT HAD AN ALLERGIC REACTION TO THE COVER PATCHES. THE PATIENT WORE THE ELECTRODES FOR FEW DAYS. THE PATIENT CONTACTED THEIR DOCTOR AND WAS SENT WOUND TAPE TO USE. IT WAS LATER REPORTED THAT A NURSE WHO CAME TO THE PATIENT¿S HOUSE ORDERED THE TAPE. THE PATIENT STATED THAT THEY HAD A STRONG REACTION TO THE COVER PATCHES AND DEVELOPED A SIGNIFICANT RASH. THE PATIENT WAS PRESCRIBED HYDROCORTISONE CREAM AND METHADONE CREAM FOR THE RASH WHICH TOOK ABOUT A WEEK TO CLEAR UP. NO FURTHER INFORMATION WAS PROVIDED. CSR ANAMARIA EMAILED THE REP IF HE KNEW ANYTHING ABOUT THE SKIN IRRITATION TO THE COVER PATCHES. UPDATE 16SEP2025 - PSS BRIANNE MCGILL CALLED THE PATIENT TO CONFIRM WHO PROVIDED THE WOUND TAPE TO THE PATIENT. THE PATIENT STATED THAT A NURSE WHO CAME TO HIS HOUSE HAD THE TAPE ORDERED, STATED IT IS A CLEAR TAPE WITH ADHESIVE ON THE EDGES, SIMILAR TO WHAT WOULD BE USED FOR A WOUND DRESSING. THE PATIENT WAS NOT SURE WHAT BRAND THE WOUND TAPE WAS. THE PATIENT STATED THAT THE COVER PATCHES MUST HAVE HAD LATEX IN THEM AS HE HAD A STRONG REACTION. STATED HE DEVELOPED A SIGNIFICANT RASH. THE PATIENT WAS PRESCRIBED HYDROCORTISONE CREAM AND METHADONE CREAM TO PUT

  Patient problems: Rash; Skin Inflammation/ Irritation

  MAUDE report 23287103 ↗
• 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 22879046 ↗
• InjuryApr 15, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED BY THE PATIENT THAT THEIR SKIN BECAME RED AND IRRITATED. THE ELECTRODES WERE CHANGED EVERY 3 DAYS. THE PATIENT HAS SENSITIVE SKIN. IT WAS LATER REPORTED THAT THE PATIENT BELIEVES THE SKIN IRRITATION WAS FROM THE COVER PATCHES AS THE IRRITATION WAS IN A CIRCLE AROUND THE 72R ELECTRODES, NOT UNDERNEATH THEM. THE PATIENT DISCONTINUED USE OF THE COVER PATCHES. THE PATIENT'S DERMATOLOGIST PRESCRIBED TRIAMCINOLONE ACETONIDE USP .1% 80 GRAMS TO BE USED TWICE PER DAY FOR 2 WEEKS AND RECOMMENDED THE PATIENT CHANGE HER ELECTRODES EVERY DAY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 21843258 ↗
• InjuryMar 27, 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 THAT SHE EXPERIENCED SKIN IRRITATION WHILE USING THE COVER PATCHES. THE SKIN IS CLEANED WITH SOAP AND WATER. THE PATIENT SPOKE WITH THE NURSE PRACTITIONER AND WAS ADVISED TO USE A DIFFERENT TAPE AND TOLD TO DISCONTINUE USING THE COVER PATCHES. NO ADDITIONAL PATIENT CONSEQUENCES/ FURTHER INFORMATION HAS BEEN REPORTED. THE COVER PATCHES WERE NOT RETURNED FOR FURTHER EVALUATION.

  Patient problems: Rash; Skin Inflammation/ Irritation

  MAUDE report 21707845 ↗
• InjuryFeb 3, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE PATIENT INDICATED THAT SHE DEVELOPED A RASH AND HAD SKIN IRRITATION WHILE USING ORTHOPAK UNIT. LATER, THE CUSTOMER SERVICE REPRESENTATIVE CALLED AND PATIENT STATED THAT SHE WORE 72R ELECTRODES WITH COVER PATCHES FOR 20-22 HOURS. THE PATIENT STATED THAT HER SKIN IS SENSITIVE TO ADHESIVES AND TOOK BREAK FROM TREATMENT FOR TWO WEEKS UNTIL THE SKIN CLEARED. ONCE SHE STARTED USING IT AGAIN, THE RASH/ SKIN IRRITATION DEVELOPED AGAIN. THE PATIENT CONTACTED THEIR PHYSICIAN AND WERE ADVISED TO SWITCH TO BHS UNIT. NO FURTHER CONSEQUENCES HAS BEEN REPORTED. THE 72R ELECTRODES AND COVER PATCHES WERE NOT RETURNED FOR FURTHER EVALUATIONS.

  Patient problems: Rash; Skin Inflammation/ Irritation

  MAUDE report 21294760 ↗
• InjuryJan 14, 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 PATIENT WOKE UP WITH A SEVERE BURNING PAIN ON HER NECK. THE PATIENT MENTIONED THAT THE COVER PATCHES WERE IRRITATING HER SKIN. IT WAS LATER REPORTED THAT THE PATIENT¿S SKIN WAS RAISED AND VERY RED AROUND THE COVER PATCHES. THE PATIENT WOKE UP AND FELT LIKE ¿HER NECK WAS ON FIRE¿ AND NOTED THE AREA WAS PUFFY. THE IRRITATION REMAINED FOR THREE DAYS. THE PATIENT STATED THAT SHE HAD A HARD TIME REMOVING THE COVER PATCHES BUT WAS ABLE TO DO SO WITH ADHESIVE SPRAY. THIS WAS THE FIRST TIME THE PATIENT EXPERIENCED AN IRRITATION WITH THE COVER PATCHES. THE PATIENT DID NOT SPEAK TO HER DOCTOR. THE PATIENT RATED THE PAIN LEVEL AS AN 8 OUT OF 10. THE PATIENT NOTED THAT SHE IS ONLY ALLERGIC TO SEAFOOD AND IS NOT TAKING BLOOD PRESSURE MEDICATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Erythema; Pain; Skin Inflammation/ Irritation

  MAUDE report 21147994 ↗
• InjuryNov 4, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE PATIENT HAS ISSUES WITH THE ELECTRODES. THE CUSTOMER SERVICE REPRESENTATIVE CALLED THE PATIENT AND FOUND THAT BOTH 72R AND 63B ELECTRODES CAUSED AN IRRITATION AND THE 63B WERE THE WORST. SHE USED THE COVER PATCHES WITH THE ELECTRODES AND HAS A SENSITIVITY TO ADHESIVES. THE CUSTOMER SERVICE REPRESENTATIVE ADVISED THE PATIENT TO STOP WEARING THE UNIT AND CONTACT HER DOCTOR AND UPDATE WHAT THEY ADVISED. LATER, AS PER COMPLAINT SPECIALIST, THE PATIENT STATED THAT THEY DEVELOPED RED, ITCHY SKIN WITH TINY BLISTERS AND NO SWELLING WHILE USING THE 72R AND 63B ELECTRODES. THE PATIENT DID NOT CHANGE OR ROTATE THE ELECTRODES FOR 3 DAYS UNTIL THE SKIN IRRITATION GOT WORST. THE PATIENT CONTACTED THEIR PHYSICIAN WHO ADVISED TO STOP WEARING THE UNIT AND PRESCRIBED OTC CREAM AND VITAMIN D SUPPLEMENTS. THE PATIENT ALSO STATED THAT THEY ARE ALLERGIC TO LATEX AND GLUE/ADHESIVES. THE PATIENT STATED THAT THE COVER PATCHES ALSO CAUSED SKIN IRRITATION AND IT RIPPED OFF HER SKIN AS SHE'S ALLERGIC TO ADHESIVES. THE ELECTRODES AND COVER PATCHES MADE THE SKIN IRRITATION WORST ALL TOGETHER. NO FURTHER INFORMATION HAS BEEN REPORTED. THE COVER PATCHES HAS NOT

  Patient problems: Blister; Rash; Skin Inflammation/ Irritation

  MAUDE report 20598765 ↗
• InjuryOct 11, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED BY THE PATIENT THAT THE COVER PATCHES HAVE CAUSED SKIN IRRITATION. THE PATIENT INDICATED THAT THE SKIN TURNED RED AND HAD BURNING SENSATION. THE PATIENT SPOKE WITH HER DOCTOR AND WAS TOLD TO JUST WEAR THE ELECTRODES WITHOUT COVER PATCHES. THE DOCTOR DID NOT PRESCRIBE ANYTHING FOR THE SKIN. THE PATIENT APPLIED HYDROCORTISONE. NO FURTHER INFORMATION HAS BEEN REPORTED. THE COVER PATCHES HAVE NOT BEEN RETURNED FOR EVALUATION.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 20433343 ↗
• InjurySep 6, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SKIN IRRITATION WHILE USING THE COVER PATCHES. IT WAS LATER REPORTED THAT THE PATIENT HAD ITCHINESS, REDNESS, WELTS, AND BLISTERS. THE AREA IS CLEANED WITH SOAP AND WATER AND THE PATIENT IS CHANGING AND ROTATING THE ELECTRODES DAILY. THE PATIENT APPLIED NEOSPORIN ON THE AFFECTED AREA. IT WAS LATER REPORTED THAT THE PATIENT SPOKE TO HER DOCTOR AND WAS INSTRUCTED TO DISCONTINUE USE DUE TO THE SKIN IRRITATION SHE HAD WITH THE ELECTRODES. NO ADDITIONAL PATIENT CONSEQUENCES/ FURTHER INFORMATION HAS BEEN REPORTED. THE COVER PATCHES WERE NOT RETURNED FOR FURTHER EVALUATION.

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

  MAUDE report 20156887 ↗
• InjuryAug 28, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED BY THE PATIENT THAT THE COVER PATCHES RIPPED OUT HIS HAIR AND TOOK OFF SKIN WHEN REMOVED. THE PATIENT CONTACTED THEIR PHYSICIAN AND WERE ADVISED TO STOP TREATING. NO FURTHER INFORMATION HAS BEEN REPORTED. THE COVER PATCHES HAVE BEEN RETURNED FOR EVALUATION.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 20088890 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS GETTING VERY BAD HEADACHES THAT STARTED 3 DAYS AGO. THE PAIN LEVEL WAS A 10 OUT OF 10. THE PATIENT HAS NOT CONTACTED HER DOCTOR BUT CONTACTED THE SALES REPRESENTATIVE WHO INSTRUCTED THE PATIENT TO CONTACT CUSTOMER SERVICE. THE PATIENT IS TAKING TYLENOL. THE PATIENT WAS ADVISED BY CUSTOMER SERVICE TO CONDUCT A TIME TEST ONCE SHE IS PAIN FREE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Headache

  MAUDE report 19948862 ↗
• InjuryJul 29, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE PATIENT HAS SKIN IRRITATION. THE CUSTOMER SERVICE REPRESENTATIVE CALLED THE PATIENT FOR DETAILS, THE PATIENT STATED THAT THE SKIN IRRITATION WAS CAUSED BY COVER PATCHES. THE SKIN WAS RED AND ITCHY WITHOUT BLISTERS OR WELTS. THE PATIENT STATED THAT SHE CONTACTED HER PHYSICIAN WHO ADVISED TO USE HOSPITAL TAPE. NO FURTHER INFORMATION HAS BEEN REPORTED. THE COVER PATCHES HAVE NOT BEEN RETURNED FOR EVALUATION.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 19850083 ↗
• InjuryApr 19, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THE PATIENT ALSO STATED THAT THE COVER PATCHES ARE CAUSING SKIN IRRITATION. THE IRRITATION IS UNDER THE COVER PATCHES. THE PATIENT CHANGES AND ROTATES AROUND 2 TO 3 BUSINESS DAYS. THE AREA IS CLEANED WITH SOAP AND WATER. THE PATIENT HAS SENSITIVE SKIN AND IS ALLERGIC TO SULFA. THE PATIENT SPOKE TO HER DOCTOR WHO TOLD HER TO MOVE THE COVER PATCHES AROUND AND TO USE BENADRYL. I ADVISED THE PATIENT NOT TO USE THE COVER PATCHES. THE PATIENT HAS BEEN USING BENADRYL OR HYDROCORTISONE CREAM OVER THE COUNTER. THE PATIENT WAS SENT REPLACEMENT 72R ELECTRODES. NO FURTHER CONSEQUENCES HAVE BEEN REPORTED AT THIS TIME.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 19142632 ↗
• InjuryJan 24, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED BY THE PATIENT INDICATES THAT SHE IS SEVERELY ALLERGIC TO THE ELECTRODES. SHE CANNOT WEAR THEM. THE SKIN IS SO BROKEN NOW. THE PATIENT NEEDS REPLACEMENTS AND POSSIBLY ADVICE ON WHAT TO DO ABOUT THE SKIN ISSUE. THE PATIENT INQUIRED IF THERE WAS A DIFFERENT ELECTRODE. THE PATIENT STATED THAT THE SKIN IRRITATION STARTED A MONTH AGO. SHE TOOK THEM OFF FOR ABOUT 10 DAYS. THE PATIENT PUT THEM BACK ON FOR 12 HOURS AND THE SKIN WAS RED WITH BUMPS AND ITCHY WITH LITTLE LESIONS AND IT LEAKED A CLEAR LIQUID. THE PATIENT USED THE COVER PATCHES IS WHAT STARTED THE SKIN IRRITATION. THE ELECTRODES WERE CHANGED EVERY DAY. THEY WERE MOVED AROUND A LITTLE. THE AREA WAS CLEAN WITH SOAP AND WATER, WITH NO WIPES. THE PATIENT DOES NOT HAVE SENSITIVE SKIN. THE PATIENT IS ALLERGIC TO LATEX. SHE HAS NO OTHER ALLERGIES OR SEASONAL ALLERGIES. THE PATIENT SPOKE TO HER DOCTOR WHO ADVISED HER TO WEAR HYDROCORTISONE CREAM ONCE THE SKIN IS NOT BROKEN AND TO TAKE BENADRYL FOR THE ITCHINESS. THE PATIENT WAS TOLD TO USE THE ELECTRODES FOR 10 DAYS. THAT IS WHEN THE SECOND ALLERGIC REACTION STARTED. THE PATIENT TOOK OFF THE ELECTRODES. SHE WAS ADVISED TO DO THE TIME TEST WITH THE 63B ELECTRODES ONCE HE

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 18576658 ↗
• InjurySep 13, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED BY THE PATIENT THAT HER SKIN BECAME VERY RED AND ITCHY WHILE USING 72R ELECTRODES AND COVER PATCHES. THE PATIENT CHANGED THEM EVERY DAY AND ROTATED AT THAT TIME. SHE WEARS THEM ON HER LOWER BACK. THE PATIENT IS NOT SURE IF THE IRRITATION WAS COMING FROM THE TAPE THAT WAS ON HER WOUND. SHE SPOKE WITH HER DOCTOR, AND HE GAVE HER MEDICATION FOR THE ITCHING. THE PATIENT STATES SHE DOES HAVE SENSITIVE SKIN. THE CUSTOMER SERVICE REPRESENTATIVE ADVISED THE PATIENT TO PAUSE TREATMENT UNTIL HER SKIN CLEARS. THE PATIENT WAS SENT REPLACEMENT 63B ELECTRODES. NO FURTHER CONSEQUENCES HAVE BEEN REPORTED AT THIS TIME.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 17737921 ↗
• InjurySep 11, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  THE PATIENT WHO STATED THAT LAST WEEK SHE HAD A SKIN REACTION. THE PATIENT STATED THAT THE IRRITATION STARTED ON (B)(6) S2023. THE PATIENT HAD A DOCTOR¿S APPOINTMENT. THE PATIENT STATED SHE WAS TOLD BY THE DOCTOR TO REMOVE THEM FOR A FEW DAYS AND TO APPLY ALOE VERA (FRESH FROM PLANT) THE SKIN WAS BURNING AND ITCHY, RED WITH LITTLE WELTS. THE PATIENT WAS CHANGING AND MOVING THE ELECTRODES AND COVER PATCHES EVERY DAY. THE AREA WAS CLEAN WITH SOAP AND WATER AND ALCOHOL WIPES. THE PATIENT WAS USING THE ALOE VERA TO REFRESH THE AREA. THE PATIENT IS ALLERGIC TO IODINE, SOFRAN AND ADHESIVE. NO SEASONAL ALLERGIES, PATIENT DOES NOT HAVE SENSITIVE SKIN. THE PATIENT'S SKIN IS NOT IRRITATED NOW, SHE IS NO LONGER USING THE COVER PATCHES AND CHANGING THE ELECTRODES DAILY. NO FURTHER CONSEQUENCES HAVE BEEN REPORTED. THE PRODUCT WAS NOT RETURNED FOR EVALUATION.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 17720808 ↗
• InjuryAug 29, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED BY THE PATIENT THAT HER SKIN BROKE OUT ABOUT 3 WEEKS AGO FROM WEARING THE COVER PATCHES. SHE CHANGED AND ROTATED THE POSITION ON HER SKIN EVERY DAY. SHE WEARS THEM ON HER NECK AND DOES HAVE SENSITIVE SKIN. THE PATIENT SPOKE WITH HER DOCTOR, AND HE TOLD HER TO PUT EUCERIN LOTION ON HER SKIN. THE CUSTOMER SERVICE REPRESENTATIVE ADVISED THE PATIENT TO TAKE A BREAK IN TREATMENT UNTIL HER SKIN WAS COMPLETELY HEALED THEN CONDUCT A TIME TEST STARTING WITH 63B ELECTRODES ONLY AND TO CALL CUSTOMER SERVICE WITH ANY UPDATES OR ISSUES. THE PATIENT WAS SENT REPLACEMENT 63B ELECTRODES. NO FURTHER CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 17646563 ↗
• InjuryJul 21, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED BY THE PATIENT THAT THE COVER PATCHES ARE CAUSING SKIN IRRITATION IN THE LUMBAR AREA. THE PATIENT CHANGES THE PATCHES EVERY ONE TO TWO DAYS. THE PATIENT STATED HE WOULD HAVE TO LEAVE THE ELECTRODES AND COVER PATCHES OFF FOR A FEW DAYS. THE SKIN CAUSES BUMPS, SIMILAR TO ACNE, IT IS ONLY ON HIS BACK, AND THERE ARE NO BLISTERS. THE PATIENT STATED HE DID GO TO HIS PRIMARY CARE PHYSICIAN AND WAS PRESCRIBED STEROID CREAM TO USE AS NEEDED. THE PATIENT HAS NOT USED THE CREAM YET, STATES THE AREA IS CLEAN WITH WATER AND SOAP, AND ALCOHOL AFTER WASHING. THE PATIENT DOES NOT HAVE SENSITIVE SKIN NOR DOES HE HAVE ANY ALLERGIES. THE PATIENT ALSO STATED THE 72R ELECTRODES DO NOT STICK TO THE SKIN, EVEN USING A DROP OF WATER DOES NOT HELP. THE PATIENT ROTATES THE ELECTRODES AND THE COVER PATCHES. 63B ELECTRODES AND COVER PATCHES WERE SHIPPED TO THE PATIENT PER THE PATIENT'S REQUEST. ZIMVIE CUSTOMER SERVICE REPRESENTATIVE TOLD THE PATIENT TO CHANGE THE ELECTRODES DAILY AND NOT TO USE THE COVER PATCHES. THE 72R ELECTRODES ARE NOT EXPECTED TO BE RETURNED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 17373488 ↗
• InjuryJan 5, 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 COVER PATCHES TOOK SKIN AND HAIR OFF HER NECK. THE PATIENT STATED THAT THE SKIN WAS NOT ITCHY AND HAD NO BLISTERS BUT THERE WERE RED SPOTS ON HER SKIN UNDER THE COVER PATCHES. THE PATIENT CLAIMED THAT SHE CHANGED ELECTRODES AND COVERS EVERY 2-3 DAYS. THE PATIENT ALSO STATED THAT HER NECK HAS SENSITIVE SKIN AND HAS ALLERGIES TO SULFA DRUGS AND MEDICAL STAPLES. THE PATIENT DOES TAKE BLOOD PRESSURE MEDICATION. THE PATIENT SPOKE TO HER HOME HEALTH NURSE WHO SUGGESTED THAT SHE DISCONTINUE USING THE COVER PATCHES AND TRY A DIFFERENT TAPE. THE PATIENT IS CURRENTLY USING KT TAPE SUCCESSFULLY. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Rash; Skin Inflammation/ Irritation

  MAUDE report 16109128 ↗
• InjuryDec 15, 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 THE COVER PATCHES ARE IRRITATING HER SKIN AS WELL. THE PATIENT STATED THAT SHE HAS SENSITIVE SKIN, AND SHE CONTACTED HER DOCTOR WHO TOLD HER TO USE PAPER TAPE, WHICH ALSO IRRITATED HER SKIN. THE PATIENT ALSO REQUESTED MORE ELECTRODES. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 15988954 ↗
• InjuryOct 5, 2022Patient-Device Incompatibility; Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED BY THE PATIENT THAT THE 63B ELECTRODES ALSO CAUSED IRRITATION EVEN WITH THE TIMED TEST. THE PATIENT STATED THAT HE WORE FOR 4-5 HOURS AND IS GETTING RASHES AGAIN. THE PATIENT STATED THAT HIS SKIN WAS COMPLETELY HEALED BE HE STARTED TREATMENT WITH THE 63B ELECTRODES AND HE IS HAVING RASHES ON BOTH LEFT AND RIGHT SIDES OF HIS FEET. THE PATIENT ALSO STATED THAT HE IS GETTING TINY BUBBLES (WELTS) THAT ARE ITCHY. THE PATIENT WAS ADVISED TO CALL THE DOCTOR AND TELL THEM THAT BOTH 72R/63B ELECTRODES CAUSED IRRITATION AND TO CALL US BACK WITH AN UPDATE. THE PATIENT ALSO STATED THAT THE RASH WAS UNDER THE COVER PATCHES AS WELL, WHEREAS WITH THE 72RS IT WAS ONLY UNDER THE ELECTRODES. IT WAS REPORTED THE PATIENT'S DOCTOR REQUESTED THE PATIENT BE SWITCHED TO THE BHS UNIT DUE TO THE RASH WITH THE ORTHOPAK. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Blister; Rash

  MAUDE report 15547411 ↗
• InjurySep 29, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF HAVING A SKIN RASH WHILE TREATING WITH THE SPINAL PAK DEVICE AT THE ELECTRODE SITE. THE PATIENT STATED THAT SHE DID NOT KNOW IF THE IRRITATION IS FROM THE ELECTRODES OR THE COVER PATCHES OR BOTH. THE PATIENT CHANGES AND ROTATES THE ELECTRODES AND COVER PATCHES DAILY. SHE CLAIMED THAT THE SKIN IRRITATION STARTED ABOUT 3 MONTHS AGO. THE PATIENT DESCRIBED THE SKIN AS RED, ITCHY, AND IRRITATED LIKE A BURN. THE PATIENT STATED THAT THEY STARTED TAKING BENADRYL. SHE DEVELOPED WELTS AND WATER BLISTERS. THE RASH SPREAD ALL OVER EVEN ON HER STOMACH. THE FIRST TIME THE PATIENT HAD A SKIN IRRITATION, THEY STATED THAT THEY USED ALOE VERA LEAVES FROM THE PLANT AND THE SKIN IRRITATION WENT AWAY. THE SECOND TIME THE PATIENT HAD A SKIN IRRITATION THEY STATED THE ALOE VERA DID NOT WORK AND THE SKIN IRRITATION GOT REALLY BAD. THE PATIENT STATED THAT SHE WENT TO THE ER WHERE A BLOOD TEST WAS TAKEN TO CHECK FOR AN INFECTION. THE PATIENT REPORTED THAT THERE WERE NO INFECTIONS. THE PATIENT WAS GIVEN BENADRYL INTRAVENOUS VEIN, AND 2 OTHER MEDICATIONS BUT DID NOT REMEMBER THE NAMES. THE PATIENT STATED THAT THEY WERE ALSO GIVEN BENADRYL 25 MG AND CLARITIN 10 MG

  Patient problems: Abrasion; Blister; Rash; Skin Inflammation/ Irritation

  MAUDE report 15506734 ↗
• InjurySep 9, 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'S WIFE THE ELECTRODE COVERS "MAKE HIM ITCHY". THE PATIENT'S WIFE CONFIRMED THAT IT WAS THE COVERS AND NOT THE ELECTRODES THEMSELVES. THE SALES REPRESENTATIVE RECOMMENDED THAT THE PATIENT SHOULD DISCONTINUE THE USE OF THE ELECTRODE COVERS AND JUST USE THE ELECTRODES. ZIMVIE CUSTOMER SERVICE CONTACTED THE PATIENT REGARDING THE COVER PATCHES. THE PATIENT'S WIFE STATED THAT THE COVER PATCHES ARE CAUSING THE SKIN TO ITCH AND BECOME RED. THE PATIENT'S WIFE DESCRIBED THE SKIN GETTING BUMPY. THE PATIENT ALSO HAD SKIN IRRITATION FROM SURGICAL TAPE AT THAT TIME. THE DOCTOR PRESCRIBED A CREAM FOR THE SKIN IRRITATION. THE PATIENT¿S WIFE STATED THAT SHE IS USING THE SAME CREAM FOR THE COVER PATCHES, BUT SHE DOES NOT HAVE THE NAME WITH HER. THE PATIENT WAS SENT REPLACEMENT 72R ELECTRODES. IT WAS LATER REPORTED ON AUG 19, 2022, THAT THE PATIENT'S WIFE STATED THAT HER HUSBAND HAS A LITTLE IRRITATION FROM THE COVER PATCHES, HIS SKIN JUST GETS A LITTLE RED. SHE STATED THAT THE DOCTOR HAS PRESCRIBED A SALVE FOR THE IRRITATION AND THE PATIENT CONTINUES TO TREAT WITH THE UNIT. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Itching Sensation; Skin Inflammation/ Irritation

  MAUDE report 15396361 ↗

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-1619-2024 · Mar 22, 2024 · Open, Classified
  48" Lead Wires, Replacement Part Number: 1067724-4
• 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-1618-2024 · Mar 22, 2024 · Open, Classified
  20" Lead Wires, Replacement Part Number: 1067724-2