Arthrex® AR-8935CL-18Recalls & reported problems
Arthrex, Inc. · KreuLock Screw, Ti, 3.5x18 · Class 2 · Implant
Data updated Oct 16, 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 00888867323124), received between Dec 12, 2024 and Dec 12, 2024 — 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 16, 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.
InjuryDec 12, 2024Break; Break
ON 10/29/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A 3024-01 11-HOLE LEFT ALPHA PLATE BROKE POSTOPERATIVELY THROUGH THE OBLONG HOLE IN THE FIRST BEND OF THE PLATE. ON (B)(6) 2024, THE PATIENT WAS IMPLANTED WITH THE PLATE, AND REVISION SURGERY IS STILL TO BE DETERMINED. PER THE SALES REPRESENTATIVE, THE PATIENT DID NOT REPORT ANY FALLS OR INJURIES. NO ADDITIONAL INFORMATION HAS BEEN REPORTED. ADDITIONAL INFORMATION RECEIVED ON 11/13/2024: DURING THE INITIAL SURGERY ON (B)(6) 2024, A 3024-011 11-HOLE LEFT ALPHA PLATE, TWO 8110-026 CORTICAL BONE SCREW, AN 8110-028 CORTICAL BONE SCREW, THREE 8110-030 CORTICAL BONE SCREWS, AN 8114-024 DOUBLE LEAD LOCK CORTICAL SCREW, AN 8114-026 DOUBLE LEAD LOCK CORTICAL SCREW, AN 8114-028 DOUBLE LEAD LOCK CORTICAL SCREW, AN 8114-030 DOUBLE LEAD LOCK CORTICAL SCREW, AN 8124-028 FULLY THREADED CANCELLOUS LOCKING SCREW, AN 8124-032 CANCELLOUS LOCKING SCREW, FULLY THREADED, AN 8124-038 FULLY THREADED CANCELLOUS LOCKING SCREW, AN 8124-040 FULLY THREADED CANCELLOUS LOCKING SCREW, AN 8124-046 FULLY THREADED CANCELLOUS LOCKING SCREW, AN 8124-048 FULLY THREADED CANCELLOUS LOCKING SCREW, AN 8124-050 FULLY THREADED CANCELLOUS LOCKING SCREW, A
Patient problems: Failure of Implant
MAUDE report 20914891 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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