Biomet SpinalPak / OrthoPak 1067724-2Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00812301020300), received between Apr 12, 2024 and Nov 7, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

3 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.

Recalls naming this device

1. Mar 22, 2024Class IIOpen, Classified

   Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment

   Z-1618-2024 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN FROM THE LEAD WIRE PRESSING UP AGAINST HER SKIN INSIDE OF HER ORTHOPEDIC BOOT. THE PATIENT STATED THAT THE LEAD WIRE SPLIT UP THE MIDDLE AND BECAME DISORGANIZED WITHIN HER BOOT, LEADING TO MORE WIRES PRESSED UP AGAINST HER SKIN. THE PATIENT WAS SENT A WARRANTY SPINALPAK UNIT BECAUSE THE ORTHOPAK UNIT WAS AT END OF OPERATION. NO FURTHER CONSEQUENCES OR FURTHER INFORMATION WAS RECEIVED. THE LEAD WIRE WAS NOT RETURNED FOR FURTHER EVALUATION.

  Patient problems: Pain

  MAUDE report 20633563 ↗
• InjuryAug 5, 2024Unintended Electrical Shock; Unintended Electrical Shock

  IT WAS REPORTED THAT THE PATIENT HAD A TOUGH TIME PULLING THE ELECTRODES AND LEAD WIRE PRONG APART SO SHE USED PLIERS AND A SILICON JAR OPENER TO PRY THEM APART. SHE DID NOT NOTICE THERE WAS AN ISSUE WITH THE PRONG BUT SHE GOT A SHOCK DOWN HER ARM SO SHE EXAMINED THE 20-INCH LEAD WIRE AND FOUND EXPOSED WIRES AND A LOOSE PRONG. IT WAS LATER REPORTED THAT THE PATIENT FELT A STRONG ELECTRICAL SHOCK FROM HER NECK TO HER RIGHT ARM. SHE ALSO EXPERIENCES TINGLING AND SLIGHT NUMBNESS IN THE ARM. THE PATIENT HAS NOT CONTACTED HER PHYSICIAN BUT HAD AN APPOINTMENT WITH HER SURGEON ON (B)(6) 2024. THE PATIENT BELIEVES THE SHOCK WAS DUE TO EXPOSED WIRES IN THE 20-INCH LEAD WIRE. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED. THE 20" LEAD WIRE WAS RETURNED FOR FURTHER EVALUATION.

  Patient problems: Numbness; Shock

  MAUDE report 19905669 ↗
• InjuryJul 3, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT RECEIVED THE LW NOTIFICATION, AND REPORTED THAT WHEN SHE IMMEDIATELY AFTER STARTING TREATMENT THAT SHE FELT THE LEAD WIRE COATING SLIPPED AND CRACKED AND CAUSED HER DISCOMFORT. AFTER GETTING OUR NOTIFICATION LETTER THE PATIENT REMEMBERED THAT SHE HAS BEEN IN PAIN SINCE JUNE OF 2023. THE PATIENT STATED THAT SHE NEVER REPORTED THE PAIN TO HIGH RIDGE OR TO HER DOCTOR. THE PATIENT STATED THAT SHE DID NOT THINK THERE MARKS ON HER BACK AND FEELS THAT THE DAMAGE WAS "INTERNAL." THE PATIENT CLAIMED THAT SHE CONTINUES TO FEEL DISCOMFORT EVERY FEW DAYS OR SOMETIMES ONCE PER WEEK. THE PATIENT REPORTED THAT THE PAIN IS AN 8 OUT OF 10. THE PATIENT CLAIMS THAT HER TREATMENT WAS DISCONTINUED IN MARCH OF 2024 BECAUSE HER BONES HAD FUSED AND THE DOCTOR WAS PLEASED WITH HER PROGRESS. THE PATIENT WAS ADVISED TO CONTACT HER DOCTOR AND REPORT THE PAIN. NO FURTHER CONSEQUENCES HAS BEEN REPORTED. THE 20" LEAD WIRE WAS NOT RETURNED FOR EVALUATION AS THE UNIT AND LEAD WIRE WAS DISCARDED UPON COMPLETION OF TREATMENT.

  Patient problems: Pain

  MAUDE report 19669991 ↗
• InjuryApr 12, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE 20" LEAD WIRE HAD EXPOSED WIRES AND BURNED HER SKIN. THE PATIENT'S SKIN WAS RES. THE PAIN WAS RATED ABOUT AN 8 OUT OF 10 FOR A FEW DAYS. THE PATIENT DID NOT TAKE PAIN MEDICATION AND DID NOT SEEK MEDICAL ATTENTION. SHE DID USE FIRST AIDE CREAM ON THE BURN. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: Burn(s); Pain

  MAUDE report 19102055 ↗

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