CANCELLOUS LOCKING SCREW, FULLY THREADED 4.0mm x 48mm 8124-048Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00848665033670), received between Jun 18, 2024 and Jul 24, 2025 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 24, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2025, A PATIENT'S LEGAL REPRESENTATIVE REPORTED VIA EMAIL THAT THE PATIENT UNDERWENT OPEN REDUCTION AND INTERNAL FIXATION OF A COMMINUTED FRACTURE OF THE LEFT HUMERAL NECK ON (B)(6) 2024. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED ONGOING COMPLICATIONS, INCLUDING PERSISTENT PAIN, NONUNION OF THE FRACTURE, AND SIGNIFICANT DISCOMFORT WITH ANY MOVEMENT OF THE LEFT SHOULDER. ON (B)(6) 2024, THE PATIENT WAS INFORMED THAT A TARGETER/DRILL GUIDE HAD BEEN INADVERTENTLY RETAINED FROM THE INITIAL PROCEDURE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 TO REMOVE THE RETAINED INSTRUMENT, DEBRIDE THE INFECTED AREA, AND REPLACE THE SURGICAL HARDWARE. ADDITIONAL INFORMATION RECEIVED ON 7/2/2025: DURING THE REVISION SURGERY ON (B)(6) 2024, THE FOLLOWING COMPONENTS WERE REMOVED: ONE 3022-005 PROXIMAL HUMERAL PLATE; TWO 8110-032 CORTICAL SCREWS; TWO 8110-035 CORTICAL SCREWS; ONE 8110-040 CORTICAL SCREW; ONE 8110-045 CORTICAL SCREW; ONE 8124-040 FULLY THREADED CANCELLOUS LOCKING SCREW; ONE 8124-044 FULLY THREADED CANCELLOUS LOCKING SCREW; THREE 8124-046 FULLY THREADED CANCELLOUS LOCKING SCREWS; TWO 8124-048 FULLY THREADED CANCELLOUS LOCKING SCREWS; AND ONE 8124-050 FULLY THREADED C

  Patient problems: Nonunion/Delayed-union Bone Fracture; Pain; Unspecified Infection

  MAUDE report 22586878 ↗
• InjuryJul 24, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 6/27/2025, A PATIENT'S LEGAL REPRESENTATIVE REPORTED VIA EMAIL THAT THE PATIENT UNDERWENT OPEN REDUCTION AND INTERNAL FIXATION OF A COMMINUTED FRACTURE OF THE LEFT HUMERAL NECK ON (B)(6) 2024. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED ONGOING COMPLICATIONS, INCLUDING PERSISTENT PAIN, NONUNION OF THE FRACTURE, AND SIGNIFICANT DISCOMFORT WITH ANY MOVEMENT OF THE LEFT SHOULDER. ON (B)(6) 2024, THE PATIENT WAS INFORMED THAT A TARGETER/DRILL GUIDE HAD BEEN INADVERTENTLY RETAINED FROM THE INITIAL PROCEDURE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 TO REMOVE THE RETAINED INSTRUMENT, DEBRIDE THE INFECTED AREA, AND REPLACE THE SURGICAL HARDWARE. ADDITIONAL INFORMATION RECEIVED ON 7/2/2025: DURING THE REVISION SURGERY ON (B)(6) 2024, THE FOLLOWING COMPONENTS WERE REMOVED: ONE 3022-005 PROXIMAL HUMERAL PLATE; TWO 8110-032 CORTICAL SCREWS; TWO 8110-035 CORTICAL SCREWS; ONE 8110-040 CORTICAL SCREW; ONE 8110-045 CORTICAL SCREW; ONE 8124-040 FULLY THREADED CANCELLOUS LOCKING SCREW; ONE 8124-044 FULLY THREADED CANCELLOUS LOCKING SCREW; THREE 8124-046 FULLY THREADED CANCELLOUS LOCKING SCREWS; TWO 8124-048 FULLY THREADED CANCELLOUS LOCKING SCREWS; AND ONE 8124-050 FULLY THREADED CAN

  Patient problems: Nonunion/Delayed-union Bone Fracture; Pain; Unspecified Infection

  MAUDE report 22586818 ↗
• 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 21536574 ↗
• 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 21504034 ↗
• InjuryDec 12, 2024Break; Break

  ON (B)(6) 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 20918621 ↗
• MalfunctionJun 18, 2024Break; Break

  ON 3/7/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (3) 8124-048 FULLY THREADED CANCELLOUS LOCKING SCREW, 4.0 MM X 48 MM, AN 8124-05 FULLY THREADED CANCELLOUS LOCKING SCREW, 4.0 MM X 50 MM, AND AN 8128-048 PARTIALLY THREADED CANCELLOUS LOCKING SCREW4.0 MM X 48 MM HAD AN ISSUE. THIS WAS DISCOVERED DURING A PROXIMAL HUMERUS FRACTURE PROCEDURE ON (B)(6) 2023. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 19558941 ↗