NA 04.226.638SRecalls & reported problems
Synthes GmbH · 4.5MM TI HEADLESS COMPRESSION SCR/SHORT THRD/38MM-STERILE · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982123411), received between Apr 10, 2024 and Apr 10, 2024 — classified as 1 malfunction.
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.
Reports received per month
Most reported problems
Device problems
- Device Slipped1
- Entrapment of Device1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 10, 2024Entrapment of Device; Device Slipped; Entrapment of Device; Device Slipped
DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT REMOVAL OF AN HCS IMPLANT FOR A FEMORAL NECK FRACTURE ORIGINALLY PLACED APPROXIMATELY 1 YEAR AGO WITH ORIF. DURING THE REMOVAL PROCEDURE, THE THREADED PART OF THE HCS KEPT IN AN IDLE SPINNING CONDITION AND COULD NOT BE REMOVED FROM THE PATIENT¿S BODY. THE REVISION PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN EXTRA 60 MINUTES OF PROCEDURE TIME. IT WAS CONFIRMED VIA X-RAY THAT NO BROKEN PIECES REMAIN WITHIN THE BODY. THE PATIENT OUTCOME IS STABLE. THIS REPORT IS FOR A 4.5MM TI HEADLESS COMPRESSION SCR/SHORT THRD/38MM-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 19081951 ↗
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- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-225Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
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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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