CANCELLOUS LOCKING SCREW, FULLY THREADED 4.0mm x 38mm 8124-038Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00848665033625), received between Apr 4, 2024 and Mar 6, 2025 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 6, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 2/20/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT A PATIENT UNDERWENT A PROXIMAL HUMERUS FRACTURE PROCEDURE ON (B)(6) 2023. A 3024-011 LEFT ALPHA PLATE, AN AR-8935-24 LOW PROFILE SCREW, TITANIUM, NON-LOCKING, AN 8110-026 CORTICAL BONE SCREW, AN 8110-024 CORTICAL BONE SCREW, TWO 8110-028 CORTICAL BONE SCREW, TWO 8124-036 CANCELLOUS LOCKING SCREW, TWO 8124-044 CANCELLOUS LOCKING SCREW, AN 8124-032 CANCELLOUS LOCKING SCREW, AN 8124-048 CANCELLOUS LOCKING SCREW, AN 8124-046 CANCELLOUS LOCKING SCREW, THREE 8114-026 DOUBLE LEAD LOCK CORTICAL SCREW, AN 8124-042 CANCELLOUS LOCKING SCREW, AN 8124-038 CANCELLOUS LOCKING SCREW, AND AN 8124-030 CANCELLOUS LOCKING SCREW WERE IMPLANTED. DUE TO NONUNION, THE PATIENT UNDERWENT A SECOND SURGERY ON (B)(6) 2024 TO HAVE AN AR-18827P-16 20 HOLE REINFORCED STRAIGHT PLATE, AN AR-18827-30 CORTICAL SCREW, AR-18827-18 CORTICAL SCREW, AR-18827V-18, AN AR-18827V-16 VAL SCREW, AN AR-18827V-22 VAL SCREW, TWO AR-18827V-20 VAL SCREW AN AR-18827V-10 VAL SCREW, AND AN ABS-2010-10 ALLOSYNC PURE IMPLANTED. ALL THE PREVIOUSLY IMPLANTED PRODUCTS DURING THE INITIAL SURGERY ON (B)(6) 2023 REMAINED IN THE PATIENT.

  Patient problems: Malunion of Bone

  MAUDE report 21536608 ↗
• InjuryMar 3, 2025Break; Break

  ON 12/19/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN ALPHA PLATE BROKE POSTOPERATIVELY. THE PATIENT WAS PICKING UP THE CAT AND FELT A BREAK. X-RAYS CONFIRM THE PLATE BROKE THROUGH THE OBLONG HOLE IN THE FIRST BEND OF THE PLATE. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED ON 2/6/2025: ON (B)(6) 2024, THE PATIENT UNDERWENT REVISION SURGERY DUE TO THE LEFT ALPHA PLATE BREAKING AND CAUSING THE REINFORCED STRAIGHT PLATE TO DISLODGE. A 3024-011 LEFT ALPHA PLATE, AN AR-8935-24 LOW PROFILE SCREW, TITANIUM, NON-LOCKING, AN 8110-026 CORTICAL BONE SCREW, AN 8110-024 CORTICAL BONE SCREW, TWO 8110-028 CORTICAL BONE SCREW, TWO 8124-036 CANCELLOUS LOCKING SCREW, TWO 8124-044 CANCELLOUS LOCKING SCREW, AN 8124-032 CANCELLOUS LOCKING SCREW, AN 8124-048 CANCELLOUS LOCKING SCREW, AN 8124-046 CANCELLOUS LOCKING SCREW, THREE 8114-026 DOUBLE LEAD LOCK CORTICAL SCREW, AN 8124-042 CANCELLOUS LOCKING SCREW, AN 8124-038 CANCELLOUS LOCKING SCREW, AND AN 8124-030 CANCELLOUS LOCKING SCREW, AN AR-18827P-16 20 HOLE REINFORCED STRAIGHT PLATE, AN AR-18827-30 CORTICAL SCREW, AR-18827-18 CORTICAL SCREW, AR-18827V-18, AN AR-18827V-16 VAL SCREW, AN AR-18827V-22 VAL SCRE

  Patient problems: Foreign Body In Patient

  MAUDE report 21504142 ↗
• InjuryDec 12, 2024Break; Break

  ON (B)(602024, 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 20917725 ↗
• MalfunctionApr 4, 2024Positioning Failure; Positioning Failure

  ON 3/12/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN 8124-034 CN LOCK SCREW, F THREAD 4.0MM X 34MM, CN LOCK SCREW, F THREAD 4.0MM X 36MM, AN 8124-036 CN LOCK SCREW, F THREAD, AND QTY. 2 OF AN 8124-038 CN LOCK SCREW, F THREAD 4.0MM X 38MM FROM LOANER SET RAR-9912S WAS NOT FUNCTIONING AND DID NOT LOCK INTO THE PLATE. THIS WAS DISCOVERED DURING A PROXIMAL HUMERUS ORIF PROCEDURE. THE CASE WAS DELAYED BY APPROXIMATELY 60 MINUTES. THE SCREWS WERE INSERTED ON POWER INITIALLY AND TIGHTENED BY HAND. THE PILOT HOLES WERE DRILLED WITH POWER. THE CASE WAS COMPLETED WITH 4.0 PARTIALLY THREADED SCREWS. THE PATIENT HAS NOT EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19045327 ↗
• MalfunctionApr 4, 2024Positioning Failure; Positioning Failure

  ON 3/12/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN 8124-034 CN LOCK SCREW, F THREAD 4.0MM X 34MM, CN LOCK SCREW, F THREAD 4.0MM X 36MM, AN 8124-036 CN LOCK SCREW, F THREAD, AND QTY. 2 OF AN 8124-038 CN LOCK SCREW, F THREAD 4.0MM X 38MM FROM LOANER SET RAR-9912S WAS NOT FUNCTIONING AND DID NOT LOCK INTO THE PLATE. THIS WAS DISCOVERED DURING A PROXIMAL HUMERUS ORIF PROCEDURE. THE CASE WAS DELAYED BY APPROXIMATELY 60 MINUTES. THE SCREWS WERE INSERTED ON POWER INITIALLY AND TIGHTENED BY HAND. THE PILOT HOLES WERE DRILLED WITH POWER. THE CASE WAS COMPLETED WITH 4.0 PARTIALLY THREADED SCREWS. THE PATIENT HAS NOT EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19043935 ↗