NA 03.641.005Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034720135), received between May 25, 2018 and May 25, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (1 report).

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.

• MalfunctionMay 25, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  (B)(6) REPORTED THE FOLLOWING EVENT: IT WAS REPORTED THAT THE RIB HOOK HOLDER WOULD NOT CLASP ONTO THE RIB HOOK. THE DEVICE MALFUNCTION OCCURRED DURING A PLANNED HARDWARE REMOVAL SURGERY ON (B)(6) 2018. THE GROWING ROD WAS REMOVED DUE TO THE GROWTH PATTERN OF THE PATIENT. THE ROD WAS REMOVED WHOLE AND INTACT USING A SIMILAR BACK-UP INSTRUMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED, WITH NO SURGICAL DELAY. PATIENT OUTCOME WAS REPORTED STABLE. THE DEVICE HAD BEEN IN USE FOR 10 YEARS. THERE WAS NO UNUSUAL USE OF THE DEVICE. THE ORIGINAL IMPLANT DATE WAS NOT PROVIDED. CONCOMITANT DEVICES REPORTED: VEPTR IMPLANT: RIB HOOK (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A RIB HOOK HOLDER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7546108 ↗