BOWTI 172802020Recalls & reported problems
Depuy Spine, LLC · BOWTI ANTERIOR BUTTRESS STAPLE 20mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034015644), received between Aug 27, 2024 and Aug 27, 2024 — classified as 1 injury.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 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 (B)(6) 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 (B)(6) 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) STAPLE, 20 MM. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).
Patient problems: Insufficient Information
MAUDE report 20081248 ↗
Other APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY devices
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- ZEVO™ Anterior Cervical Plate System 7710015Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall1 report
- XLP 7565050Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- Elegance® Anterior Cervical Plate 53430344Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- ATLANTIS® Anterior Cervical Plate System 876-170Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- XLP 7565060Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- Elegance® Anterior Cervical Plate 53430113Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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