OSCAR 3 1 (REF OHRE2001SU)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 18056099649964), received between Feb 27, 2020 and Feb 27, 2020 — classified as 1 malfunction.

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.

• MalfunctionFeb 27, 2020Mechanical Problem; Mechanical Problem

  THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: PRODUCT CODE: OHRE2001SU (LONG EXTENSION REDUCER BAR FOR SINGLE USE PROBES) . BATCH NUMBER: G160307. 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: NO RESPONSE RECEIVED. SURGERY DESCRIPTION: ARTHROPLASTY REVISION. PATIENT INFORMATION: (B)(6) YEARS, MALE. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: "PROBLEM OCCURRED WEEK COMMENCING (B)(6) 2020, MR (B)(6) OPERATING. REPORTED TO BE "NOT WORKING" COULD NOT BE MORE SPECIFIC, ALSO EXTENSION BAR BROKE DURING PROCEDURE. I UNDERSTAND THESE HAVE BEEN RETRIEVED. POOR FEEDBACK RELEASE ALL SWITCHES. HAND PIECES CANNOT MELT CEMENT". THE COMPLAINT REPORT FORM ALSO INDICATED: THE DEVICE FAILURE CAUSED ADVERSE EFFECTS ON PATIENT (LOSS OF FRACTURE REDUCTION, LOSS OF ACHIEVED CORRECTION). THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. THE EVENT LED TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE (APPROXIMATELY 30 MINUTES). INFORMATION ABOUT NEED OF ADDITIONAL SURGERY OR MEDICAL INTERVENTION IS NOT AVAILABLE. CO

  Patient problems: No Code Available

  MAUDE report 9761945 ↗