AOS CAPTURED CORTICAL SCREW 5.0mm x 36mm 8001-036Recalls & reported problems
Advanced Orthopaedic Solutions, Inc. · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00848665019131), received between Aug 29, 2022 and Jun 18, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated1
- Device Slipped1
Patient problems
- Failure of Implant1
- Implant Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING AN INTERTROCHANTERIC FRACTURE SURGERY THE LAG SCREW AND ANTI-ROTATION SCREW BACKED OUT OF THE NAIL AND THE NAIL LAGSCREW HOLE LOOKED DAMAGED. IT WAS FURTHER REPORTED THAT THE PATIENT WENT IN FOR A TOTAL HIP REPLACEMENT ON THE (B)(6) 2024. UPDATE DW 21-MAY-2025 DURING THE EVALUATION IT WAS FOUND THAT IN ADDITION A 8001-036 WAS RETURNED AS WELL.
Patient problems: Failure of Implant
MAUDE report 22282287 ↗InjuryAug 29, 2022Device Slipped
ON 6/16/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT ON (B)(6) 2022, A PATIENT UNDERWENT SURGERY FOR A TROCHANTERIC FRACTURE AND AN ARTHREX SHORT TROCHANTERIC NAIL WAS IMPLANTED. TWELVE DAYS POST OPERATIVE, WHILE TRYING TO STAND FROM THE WHEELCHAIR, PATIENT FELT LIKE THE NAIL HAD EXPLODED OUT OF THE LEG. X-RAYS WERE TAKEN OF THE IMPLANTS AND WHILE IT IS STILL UNKNOWN WHAT HAPPENED, IT SEEMS LIKE THE LOCKING RING WAS NOT ABLE TO HOLD THE LAG SCREW IN PLACE. AS OF NOW, THE SURGEON IS NOT PLANNING ON A REVISION SURGERY AND WILL FOLLOW UP AGAIN WITH THE PATIENT IN TWO WEEKS. ADDITIONAL INFORMATION PROVIDED ON 08/08/2022, IT WAS REPORTED THAT ANOTHER 4 WEEK POST OP OCCURRED ON (B)(6) 2022 AND X-RAYS SHOWED THAT THE NAIL HAD FURTHER BACKED OUT. A REVISION SURGERY TOOK PLACE ON (B)(6) 2022, AT THIS TIME THE 1031-200 GALILEO® TROCH NAIL,1099-100 GALILEO LAG SCREW, AND 8001-036 CAPTURED CORTICAL SCREW WERE EXPLANTED. THE SURGEON CONVERTED TO A TOTAL HIP ARTHROPLASTY.
Patient problems: Implant Pain
MAUDE report 15310510 ↗
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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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