NA 2361-5065SRecalls & reported problems
Stryker GmbH · Advanced Locking Screw · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327381634), received between Nov 23, 2021 and Apr 18, 2024 — classified as 2 injuries, 3 malfunctions.
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
- Device Difficult to Setup or Prepare1
- Device Dislodged or Dislocated1
- Failure to Advance1
- Fracture1
- Material Deformation1
- Mechanical Jam1
- Migration1
Patient problems
- Failure of Implant3
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryApr 18, 2024Break; Fracture; Break; Fracture
IT WAS REPORTED BY THE SALES REP THAT A RETROGRADE T2 ALPHA FEMUR NAIL AND AN UNKNOWN SCREW BROKE POSTOPERATIVELY. REVISION SURGERY TOOK PLACE ON (B)(6) 2024.
Patient problems: Failure of Implant
MAUDE report 19134983 ↗MalfunctionSep 1, 2022Device Difficult to Setup or Prepare; Failure to Advance; Material Deformation; Device Difficult to Setup or Prepare; Failure to Advance; Material Deformation
AS REPORTED: ADVANCED LOCKING SCREW CROSS THREADED INTO OBLIQUE HOLE. SCREW WOULD NOT ADVANCE (OR BACK OUT) WITH POWER OR HAND TO THE POINT OF STRIPPING THE SCREW. EVENTUALLY WAS ABLE TO PUT ON SHORT CAPTURE SCREWDRIVER TO BARELY REMOVE SCREW. REPLACED WITH A STANDARD LOCKING SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15335673 ↗MalfunctionMar 31, 2022Mechanical Jam; Mechanical Jam
T2 ALPHA ADVANCED LOCKING SCREW WAS COLD WELDED TO THE NAIL. EVENTUALLY IT WAS ABLE TO BE REMOVED, AND WAS REPLACED WITH A STANDARD LOCKING SCREW. ADDITIONALLY, IT WAS REPORTED; THE PROCEDURE WAS DELAYED BUT THE LENGTH OF THE DELAY IS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13964480 ↗MalfunctionMar 8, 2022Migration; Migration
IT WAS REPORTED: "ONE MONTH POSTOPERATIVE EXAMINATION SHOWED BACKOUT OF THE ADVANCED LOCKING SCREW. AT THE MOMENT, NO ADDITIONAL INFORMATION IS AVAILABLE AND NO REVISION IS PLANNED."
Patient problems: Failure of Implant
MAUDE report 13693463 ↗InjuryNov 23, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED: "THE DOCTOR IMPLANTED A T2 ALPHA TIBIA NAIL. AFTER A FEW MONTHS THE ADVANCED LOCKING SCREWS BACKED OUT." AS A RESULT THE IMPLANTS WERE EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 12860045 ↗
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- 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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