PERCUTANEOUS COMPRESSION PLATE (PC.C.P) 1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 18032568865752), received between Apr 21, 2020 and Apr 21, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Mechanical 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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 21, 2020Mechanical Problem; Mechanical Problem

  THE INFORMATION PROVIDED BY LOCAL DISTRIBUTOR INDICATES: - DEVICE CODE: (B)(4). - BATCH NUMBER: AE1800. - QUANTITY: 1. - HOSPITAL NAME: (B)(6). - SURGEON'S NAME: (B)(6). - DATE OF INITIAL SURGERY: (B)(6) 2020. - BODY PART TO WHICH DEVICE WAS APPLIED: FEMUR. - SURGERY DESCRIPTION: FRACTURE TREATMENT. - PATIENT'S INFORMATION: UNKNOWN. - PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE. - TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. - EVENT DESCRIPTION: WHILE TURNING THE SCREWDRIVER (GRIP 3) COUNTERCLOCKWISE (AS SHOWN ON PAGE 20 OPERATIVE TECHNIQUE) THE HANDLE LOOSENED FROM THE SHAFT. THE COMPLAINT REPORT FORM ALSO INDICATED: - THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON PATIENT. - THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. - THE EVENT LED TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE (TOTAL DELAY 30 MINUTES). - AN ADDITIONAL SURGERY WAS NOT REQUIRED. - A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. - COPIES OF THE OPERATIVE REPORT ARE NOT AVAILABLE. - COPIES OF THE X-RAY IMAGES ARE NOT AVAILABLE. - PRODUCT IS AVAILABLE FOR RETURN. - PATIENT CURRENT HEALTH CONDITIONS: GOOD. MANUFACTURER REF: (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9980291 ↗