POWEREASE™ Instruments 2343431MRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994905567), received between Nov 19, 2019 and Nov 19, 2019 — classified as 1 malfunction.

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

2 other recalls cover devices cleared under the same FDA submission (K111520); 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 16, 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.

• MalfunctionNov 19, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LUMBAR FUSION SURGERY AT TWO LEVEL OF LUMBAR DUE TO DEGENERATIVE DISC DISEASE (DDD). INTRA-OP, THE LOCKING MECHANISM WAS NOT WORKING TO LOCK ON THE FIRST PEDICLE SCREW WHEN THE GREEN PORTION OF THE SLEEVE WAS TURNED. IT WAS THEN DISCOVERED THAT THE SLEEVE LOCK WAS BROKEN. NO ANY FRAGMENTS OF THE INSTRUMENT REMAINING IN THE PATIENT'S BODY. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9339650 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111520. One submission often covers many models, so check the product and lot details in each record.

• Z-2461-2025 · Jul 17, 2025 · Open, Classified
  IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. The IPC POWEREASE System is indicated for drilling, tapping, and driving screws and working end attachments
• Z-0952-2015 · Dec 3, 2014 · Terminated
  POWEREASE Instruments Set Screw Breakoff Instrument, REF 2346010, Medtronic Sofamor Danek, USA, Inc. Spinal surgical instrumrent.