Arthrex® AR-8933VCL-14Recalls & reported problems
Arthrex, Inc. · VAL KreuLock Screw, Ti, 3.0x14 · 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 00888867324169), received between Aug 7, 2025 and Aug 7, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (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
- Patient Device Interaction Problem1
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.
InjuryAug 7, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
ON (B)(6) 2025, A PHONE REPORT WAS RECEIVED FROM A PATIENT WHO UNDERWENT AN MTP JOINT ARTHRODESIS WITH DORSAL PLATE AND SCREW FIXATION ON (B)(6) 2024 FOR TREATMENT OF HALLUX RIGIDUS OF RIGHT FOOT. DURING THE PROCEDURE, A PLATE PRODUCT IDENTIFIED ONLY AS ¿MAX FORCE¿ WAS IMPLANTED. IN (B)(6) 2025, APPROXIMATELY SIX MONTHS POSTOPERATIVELY, THE PATIENT REPORTED EXPERIENCING A LOUD "POP" WHILE WALKING. RADIOGRAPHS TAKEN ON (B)(6) 2025 CONFIRMED THAT THE IMPLANTED PLATE HAD FRACTURED. REVISION SURGERY IS SCHEDULED FOR (B)(6) 2025 WITH THE SAME SURGEON AT THE ORIGINAL FACILITY. THE PATIENT DID NOT PROVIDE ANY ADDITIONAL INFORMATION. DURING A PHONE CALL WITH THE SALES REPRESENTATIVE ON (B)(6) 2025, IT WAS REPORTED THAT DURING THE ORIGINAL PROCEDURE ON (B)(6) 2024, THE SURGEON EXPRESSED CONCERN THAT THE JOINT HAD BEEN SIGNIFICANTLY SHORTENED FOLLOWING THE REAMING PROCESS. TO COMPENSATE AND RESTORE PROPER LENGTH, A LIFENET BONE DOWEL REVISION WAS ADDED, AND THE BONE WAS ADJUSTED ACCORDINGLY. THE PLATE WAS IMPLANTED OVER THE BONE DOWEL. APPROXIMATELY THREE WEEKS AGO, THE PATIENT EXPERIENCED A ¿POP¿ WHILE ENGAGED IN PHYSICAL ACTIVITY, DESCRIBED BY THE SALES REPRESENTATIVE AS POSSIBLY ¿OUT GARD
Patient problems: Failure of Implant
MAUDE report 22741807 ↗
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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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