VIPER 186788055Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034131764), received between Aug 30, 2018 and Aug 30, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

1 other recall cover devices cleared under the same FDA submission (K071860, K111136); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 30, 2018Break; Break

  IT WAS REPORTED BY A PATIENT'S FIANCE, BETWEEN 2012 AND 2018 PATIENT RECEIVED SPINAL FUSIONS FROM T3 TO SCROTUM WITH SPINAL FIXATION RODS FROM THORACIC TO SCROTUM. FROM HER MEDICAL RECORDS, IT WAS CONFIRMED RODS, SCREWS AND FUSION PLATE WERE MADE BY DEPUY. THE ROD ON THE RIGHT SIDE HAS BROKEN TWICE. SHE NEEDS TO HAVE IT REPAIRED. PATIENT NEEDS AN MRI AND IS UNSURE WHICH MATERIAL THE IMPLANTS ARE MADE FROM. PATIENT HAS REACHED OUT TO DOCTOR. HOWEVER, DOCTOR CANNOT VERIFY MATERIAL OF IMPLANTS

  Patient problems: Spinal Column Injury

  MAUDE report 7834000 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071860, K111136. One submission often covers many models, so check the product and lot details in each record.

• Z-1674-2015 · Apr 21, 2015 · Terminated
  EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150, UDI NUMBER (if applicable): GTIN: 10705034032467