AOS CAPTURED CORTICAL SCREW 4.2mm x 35.0mm 8002-035Recalls & reported problems
Advanced Orthopaedic Solutions, Inc. · 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 00848665019414), received between Oct 12, 2023 and Oct 12, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 12, 2023Break; Break
ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A 4.2 MM X 45MM DISTAL SCREW AND A 5.0 MM X 65 MM PROXIMAL SCREW FRACTURED. WHEN INSERTING THE 4.2 MM SCREW, IT COMPLETELY FRACTURED, AND ONE-THIRD OF THE SCREW, THE THREADED DISTAL PORTION, NEEDED TO BE REMOVED VIA LATERAL INCISION AND BARREL REAMING. THE 5.0 SCREW WAS PARTIALLY FRACTURED AND WAS PULLED OUT COMPLETELY USING THE HEX DRIVER AND CAPTURE ROD. THE SURGEON DID NOT APPEAR TO BE USING UNREASONABLE FORCE AND HAD NOT YET GOTTEN THE HEAD OF THE REDUCTION BOLT FULLY THREADED DOWN. THE CASE WAS COMPLETED USING NEW CORTICAL SCREWS TO ACHIEVE THE NEEDED COMPRESSION. THIS WAS DISCOVERED DURING A TIBIAL NAIL PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON 9/25/2023: THE PART NUMBERS INVOLVED IN THE PROCEDURE WERE AN 8002-035 CAPTURED CORTICAL SCREW, 4.2MM X 35MM, AND AN 8001-065 CAPTURED CORTICAL SCREW, 5.0MM X 65MM. THE CASE WAS DELAYED OVER NINETY MINUTES, BUT THE SALES REPRESENTATIVE IS UNSURE IF ADDITIONAL ANESTHESIA WAS ADMINISTERED TO THE PATIENT. THE CASE WAS COMPLETED USING ANOTHER 8002-035 CAPTURED CORTICAL SCREW AND AN 8001-065 CAPTURED CORTICAL SCREW.
Patient problems: Failure of Implant
MAUDE report 17919953 ↗
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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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