BOWTI 172803025Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034015675), received between Feb 22, 2019 and Aug 27, 2024 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON APRIL 05, 2021 THE SURGEON AND SURGICAL TEAM PERFORMED SEVERAL PROCEDURES INCLUDING AN ANTERIOR LUMBAR INTERBODY FUSION AND BONE GRAFT. ALL PROCEDURES WERE PERFORMED PURSUANT TO THE STANDARD OF CARE, WITH NO DEVIATION FROM THE SURGICAL STEPS. THESE PROCEDURES INCLUDED THE IMPLANTATION OF THE DEPUY PRODUCTS. ON APRIL 07, 2021 THE SURGEON AND SURGICAL TEAM PERFORMED SEVERAL PROCEDURES INCLUDING REVISION PROCEDURES, OSTEOTOMY PROCEDURES, AND REMOVAL OF HARDWARE. DURING THE SPINE PROCEDURE THE SURGEON CUT THE DEPUY TRANSITION RODS BETWEEN THE C6 AND T1 SPINAL LEVELS. THE CERVICAL PORTION OF THESE WERE REMOVED. THE SET CAPS WERE REMOVED. LATERAL MASS SCREWS AT C4-C5 AND C6 WERE REMOVED. THE SURGEON ALSO OBSERVED THAT THE FUSION MASS AROUND C3-4 WAS WEAK AND WAS EASILY SPREAD APART. THE SURGEON THEN IMPLANTED CERVICAL RODS WITH CONNECTORS TO THE T1 LEVEL. THESE PROCEDURES INCLUDED THE IMPLANTATION OF THE DEPUY PRODUCTS. THIS REPORT IS FOR ONE (1) ANTI BACKOUT SCREW, 25 MM. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 20080810 ↗
• 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, 20MM (PART #: 172803020, LOT #: WA24073, 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, 25MM. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: Injury

  MAUDE report 9812942 ↗
• InjuryFeb 22, 2019Migration; Migration

  IT WAS REPORTED DOCTOR PERFORMED A L5-S1 ALIF SURGERY WITH SYNCAGE EVOLUTION AND BOWTI ON (B)(6) 2019. SURGERY WAS COMPLETED WITH NO COMPLICATIONS OR DELAYS. DOCTOR TOOK AT THE START OF STAGE 2 OF THE SURGERY (B)(6) 2019 AND NOTICED THAT THE BOWTI AND SYNCAGE BACKED OUT FROM ORIGINAL PLACEMENT ON DAY ONE OF SURGERY. DOCTOR IS ORDERING A CT SCAN THIS EVENING. BASED OFF THE CT SCAN HE IS GOING TO DETERMINE IF THE PATIENT WILL NEED TO BE BROUGHT BACK TO SURGERY TOMORROW. I WAS NOT PRESENT OR INVOLVED IN STAGE TWO OF SURGERY (B)(6) 2019. DID THE PATIENT EXPERIENCE A POST-OP DEVICE MALFUNCTION? YES. IF YES, PLEASE DESCRIBE. IMPLANTS MOVED ANTERIOR. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? UNKNOWN. DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? UNKNOWN. IF NO, WAS THERE ANY ADDITIONAL MEDICAL INTERVENTION REQUIRED SUCH AS X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS? CT SCAN. PATIENT STATUS/ OUTCOME / CONSEQUENCES: UNKNOWN. PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? UNKN

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 8363380 ↗