BOWTI 172803020Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034015668), received between Mar 10, 2020 and Mar 10, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Device Slipped” (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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 10, 2020Device Slipped; Device Slipped

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING L3-S1 ALIF SURGERY, UPON INSTRUMENTING THE L4/L5 LEVEL AND AFTER INSERTING MTF ALIF ALLOGRAFT INTO THE DISC SPACE, THE SURGEON REQUESTED TO USE THE DEPUY BOWTI ANTERIOR BUTTRESS STAPLE. HE POSITIONED THE BOWTI AND THEN USED THE AWL TO PERFORATE THE CORTEX AND PREPARE A HOLE FOR THE SCREW. WHEN INSERTING THE SCREW, HE NOTICED THAT THE PURCHASE WASN'T STRONG AND THAT THE SCREW SEEMED TO FALL INTO THE HOLE RATHER THAN THREAD IN. HE THEN REMOVED THE BOWTI STAPLE AND SCREW AND MOVED THE IMPLANT OVER SO THAT HE COULD CREATE A NEW HOLE FOR THE SCREW. AGAIN, HE EXPERIENCED THE SAME PROBLEM. AGAIN, HE REMOVED THE IMPLANT AND CHOSE NOT TO RE-INSTRUMENT WITH THE BOWTI. THERE WAS A SURGICAL DELAY OF FIFTEEN (15) MINUTES. PATIENT STATUS IS UNKNOWN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICE REPORTED: ANTI BACKOUT SCREW, 25MM (PART #: 172803025, LOT #: WA24956, QUANTITY 1); STAPLE, 24MM (PART #: 172802024, LOT #: WA21807, QUANTITY 2); SCREWS (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) ANTI BACKOUT SCREW, 20MM. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: Injury

  MAUDE report 9812932 ↗