Biomet SpinalPak / OrthoPak 106130-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00812301020188), received between Dec 4, 2019 and Mar 5, 2021 — classified as 13 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (11 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryMar 5, 2021Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

  IT WAS REPORTED BY THE SALES REP THAT THE PATIENT STATED THAT THE SHE GOT A SKIN IRRITATION ON THE LOWER BACK FROM LT-4500 ELECTRODES. THE IRRITATION STARTED IN JANUARY. THE SKIN IS HOT, BUMPY RED, ITCHY, BLISTERS AND OOZY. THE PATIENT STATED THAT IT LOOKS LIKE A BURN. THE IRRITATION WAS STRICTLY UNDER THE ELECTRODES. THE ELECTRODES WERE CHANGED EVERY OTHER DAY. THE PATIENT STATED THAT HER DOCTOR TOLD HER TO CHANGE THE POSITION TO ACROSS FROM EACH OTHER. THE AREA WAS CLEANED WITH SOAP AND WATER. NO WIPES. NO NEW PRODUCT. THE PATIENT CALLED THE DOCTOR ABOUT THE IRRITATION. THE DOCTOR TOLD THE PATIENT TO CONTACT THE SALES REP. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED. THE LT-4500 ELECTRODES WERE NOT RETURNED FOR FURTHER EVALUATION.

  Patient problems: Blister; Skin Inflammation/ Irritation

  MAUDE report 11423646 ↗
• InjuryOct 15, 2020Patient-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 DEVELOPED SKIN IRRITATION FROM ALL 3 TYPES OF THE ELECTRODES; THE LT-4500 ELECTRODES, THE 72R ELECTRODES, AND THE 63B. THE PATIENT HAD A RASH. THE DESCRIBED HER SKIN AS RED AND ITCHY WITH BUMPS AND WELTS. THE PATIENT WORE THE 63B ELECTRODES AND AFTER 5 HOURS HER BECAME RED AND ITCHY. SHE WAITED FOR THE SKIN TO HEAL. THE TRIED THE LT-4500 ELECTRODES AND AFTER 6 HOURS HER SKIN BECAME RED AND ITCHY. THE PATIENT REPORTED THAT SHE HAS SENSITIVE SKIN. THE PATIENT CONTACTED HER DOCTOR AND WAS ADVISED TO DISCONTINUE TREATMENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Skin Inflammation/ Irritation; Skin Irritation

  MAUDE report 10687783 ↗
• InjuryAug 20, 2020Off-Label Use; Patient-Device Incompatibility; Off-Label Use; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING SKIN IRRITATION FROM THE SPINALPAK ASSEMBLY. THE PATIENT WAS USING THE 63B AND 72R ELECTRODES WHEN SHE FIRST STARTED TO DEVELOP THE SKIN IRRITATION. THE SKIN WAS RED AND ITCHY WITH LITTLE BUMPS. THE PATIENT WENT TO SEE HER DOCTOR AND WAS ADVISED TO ROTATE THE POSITION OF THE ELECTRODES. THE PATIENT TOOK THE 72R ELECTRODES OFF AFTER 5 MINUTES BECAUSE SHE COULD NOT TOLERATE THE ITCHING. THE PATIENT USED THE 63B ELECTRODES BUT TOOK THEM OFF ONCE HER SKIN BECAME IRRITATED AND STOPPED WEARING THEM FOR TWO WEEKS. THE PATIENT WAS SENT LT-4500 ELECTRODES AND WAS ADVISED TO PERFORM A TIMED TEST WITH THE ELECTRODES. THE PATIENT LATER REPORTED THAT SHE IS SEVERELY ALLERGIC TO ALL OF THE ELECTRODES AND COVER PATCHES. THE PATIENT'S DOCTOR ADVISED THE PATIENT TO DISCONTINUE USE OF THE SPINALPAK. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Skin Irritation

  MAUDE report 10432935 ↗
• InjuryJun 10, 2020Patient-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 DEVELOPED SKIN IRRITATION FROM THE 63B, 72R, AND LT-4500 ELECTRODES. THE PATIENT STATED THAT THE IRRITATION STARTED THE FIRST DAY SHE STARTED WEARING THE ELECTRODES. THE PATIENT WAS WEARING THE ELECTRODES ON HER LUMBAR SPINE. THE PATIENT STARTED WEARING THE LT-4500 ELECTRODES AND HER SKIN BECAME RED, ITCHY, AND RAISED WITH BLISTERS. THE PATIENT USED A PRESCRIPTION THAT SHE HAD AT HOME FOR PREVIOUS SKIN IRRITATION. THE PRESCRIPTION HEALED THE IRRITATION. THE PATIENT CHANGED TO USING THE 72R ELECTRODES. THE PATIENT DEVELOPED THE SAME IRRITATION IMMEDIATELY. THE PATIENT CONTINUED USING THE PRESCRIPTION TO CLEAR THE SKIN IRRITATION. THE PATIENT TRIED WEARING THE 63B ELECTRODES AND AGAIN EXPERIENCED THE SAME IRRITATION. AFTER A WEEK OF WEARING THE 63B ELECTRODES, THE PATIENT WENT TO AN URGENT CARE CENTER. THE PATIENT WAS ADVISED THAT SHE HAD CONTACT DERMATITIS AND WAS PRESCRIBED MEDICATION TO APPLY THREE TIMES TO THE AFFECTED AREA DAILY. THE PATIENT WENT TO SEE HER SURGEON AND THE SURGEON LOOKED AT THE SKIN IRRITATION AND ADVISED THAT IT WAS GOOD SHE WAS ON THE PRESCRIBED STEROID CREAM. A COUPLE OF WEEKS LATER, THE PATIENT CALLED HER SURGEON BECAUSE THE

  Patient problems: Skin Inflammation/ Irritation; Skin Irritation

  MAUDE report 10139527 ↗
• InjuryMay 27, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT DEVELOPED SORES FROM THE LT-4500, 72R, AND 63B ELECTRODES. THE PATIENT WAS USING THE DEVICE ON HER CERVICAL SPINE. THE PATIENT REPORTED THAT SHE DEVELOPED LARGE OPEN SORES FROM ALL THREE TYPES OF ELECTRODES. THE PATIENT SAID THAT HER NECK PAIN HAS IMPROVED AND SHE IS NO LONGER USING THE DEVICE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Skin Irritation

  MAUDE report 10093823 ↗
• InjuryMay 7, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A RASH FROM USING THE LT-4500 ELECTRODES. THE PATIENT WAS USING THE LT-4500 ELECTRODES ON HER LUMBAR SPINE. THE PATIENT SAID THAT SHE NOTICED THE RASH THE FIRST TIME SHE USED THE UNIT. THE PATIENT REACHED OUT TO HER DOCTOR AND WAS PRESCRIBED A MEDICATION TO TREAT THE RASH. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Rash

  MAUDE report 10034221 ↗
• InjuryApr 28, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN, BRUISING, AND SCARRING FROM THE LT-4500 ELECTRODES. THE PATIENT WAS USING THE ELECTRODES ON THE CERVICAL REGION OF HIS SPINE. THE PATIENT SAW HIS DOCTOR AND WAS PRESCRIBED AN OINTMENT. THE DOCTOR ADVISED THE PATIENT TO STOP WEARING THE UNIT UNTIL THE SKIN COMPLETELY HEALS. THE PATIENT SAID THAT HIS SKIN IS HEALING. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Bruise/Contusion; Pain; Scarring

  MAUDE report 10004304 ↗
• InjuryApr 22, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT DEVELOPED SKIN IRRITATION FROM THE LT-4500 AND 72R ELECTRODES. THE PATIENT WAS APPLYING THE ELECTRODES TO THE LUMBAR REGION OF HER SPINE. THE PATIENT DESCRIBED HER SKIN AS RED AND ITCHY WITH BLISTERS, WELTS, AND SMALL BUMPS. THE PATIENT STOPPED USING THE DEVICE FOR FOUR DAYS. THE PATIENT STATED THAT THE SKIN DEVELOPED SCABS AND IT IS SCARRING. THE PATIENT IS USING AN OVER THE COUNTER MEDICATION TO TREAT THE SKIN IRRITATION. THE PATIENT DID CALL HER DOCTOR AND THE DOCTOR ADVISED THE PATIENT TO WEAR THE ELECTRODES ONLY AT NIGHT. THE PATIENT SAYS THAT THE SKIN IRRITATION HAS LESSENED SINCE BREAKING UP THE TREATMENT TIME. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Skin Irritation

  MAUDE report 9987353 ↗
• InjuryMar 17, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SKIN IRRITATION FROM THE 72R AND LT-4500 ELECTRODES. THE PATIENT DESCRIBED THE SKIN AS RED AND ITCHY WITH BLISTERS AND WELTS. INITIALLY, THE IRRITATION WAS STRICTLY UNDER THE ELECTRODES BUT THE IRRITATION BEGAN TO SPREAD. THE PATIENT DID CONTACT THE SURGEON REGARDING THE SKIN IRRITATION. THE SURGEON ADVISED THE PATIENT TO STOP USING THE UNIT AND PRESCRIBED AN OINTMENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Skin Irritation

  MAUDE report 9841673 ↗
• InjuryJan 24, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN FROM THE SPINALPAK STIMULATOR. THE PATIENT WAS USING THE SPINALPAK STIMULATOR WITH THE LT-4500 AND 72R ELECTRODES. THE PATIENT STATED THAT THE PAIN WAS ON THE RIGHT SIDE OF HER BACK IN THE KIDNEY AREA AND ACROSS THE HIP. THE PATIENT STATED THAT THE PAIN IS BELOW THE SKIN AND THE PAIN LEVEL IS A 10, ON A SCALE OF 1-10. THE PATIENT STOPPED USING THE STIMULATOR AND THE PAIN DID NOT GO AWAY. THE PATIENT CALLED THEIR DOCTOR AND WAS PRESCRIBED IBUPROFEN AND ADVISED NOT TO USE THE STIMULATOR FOR A WEEK. THE PATIENT BELIEVES THAT THE PAIN WAS FROM THE INFLAMMATION OF THE INCISION. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Pain

  MAUDE report 9627090 ↗
• InjuryJan 13, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SKIN IRRITATION FROM THE ELECTRODES. THE PATIENT SAID THAT THE SKIN WAS RED, ITCHY, AND DEVELOPED WELTS. THE PATIENT SAW THEIR SURGEON FOR THE IRRITATION AND WAS TOLD TO CONTINUE USING THEM AND TO REACH OUT TO A DERMATOLOGIST. THE PATIENT SAW THEIR DERMATOLOGIST AND WAS DIAGNOSED WITH A SKIN DISORDER. THE PATIENT CONTINUED USING THE ELECTRODES AND TRIED CHANGING THEM EVERY DAY. INITIALLY, IT WORKED BUT THE SKIN IRRITATION CAME BACK. THE PATIENT CALLED THEIR PRIMARY PHYSICIAN AND WAS PRESCRIBED FLUOCINONIDE 0.05% CREAM. THE CREAM CLEARED THE IRRITATION. UPON USING THE ELECTRODES AGAIN, THE SKIN IRRITATION DEVELOPED WITHIN HALF A DAY. THE PATIENT REACHED OUT TO THEIR SURGEON AGAIN AND WAS TOLD TO KEEP USING THE UNIT. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Skin Irritation

  MAUDE report 9581527 ↗
• InjuryDec 5, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SKIN IRRITATION FROM USING THE ELECTRODES AND COVER PATCHES FOR THE SPINALPAK. THE PATIENT SAID THAT THE SKIN WAS RED AND ITCHY WITH LITTLE BUMPS AND SCABS. THE PATIENT SAID THAT THE SKIN IRRITATION WAS PAINFUL. THE PATIENT TRIED TO BREAK UP HER TREATMENT TIME AND USE DIFFERENT ELECTRODES BUT THE SKIN IRRITATION STILL OCCURRED. THE PATIENT CONTACTED HER DOCTOR WHO ADVISED HER TO STOP USING THE SPINALPAK. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Skin Irritation

  MAUDE report 9415378 ↗
• InjuryDec 4, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING SKIN IRRITATION FROM USING THE 72R ELECTRODES WITH THE SPINALPAK UNIT. THE PATIENT STATED THAT HER SKIN WAS VERY ITCHY AND IT MADE IT DIFFICULT TO SLEEP AT NIGHT. THE PATIENT TRIED USING THE LT-4500 ELECTRODES WHICH CAUSED AN IRRITATION ON HER SKIN AS WELL. THE PATIENT CONTACTED HER DOCTOR WHO ADVISED HER TO DISCONTINUE USING THE SPINALPAK UNIT. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Itching Sensation; Skin Irritation

  MAUDE report 9413004 ↗

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