OSCAR 3 1 (REF OHB300/2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 18056099649995), received between Apr 15, 2021 and Apr 15, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Electrical /Electronic Property 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 15, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE INFORMATION INITIALLY PROVIDED BY LOCAL DISTRIBUTOR INDICATES: DATE OF INITIAL SURGERY: (B)(6) 2021. SURGERY DESCRIPTION: ARTHROPLASTY REVISION. PATIENT'S INFORMATION: (B)(6) YEARS, MALE, IN GOOD HEALTH CONDITION. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: "REPETITION OF AN ERROR MESSAGE "POOR SIGNAL"; DIFFICULTY TO PROGRESS WITH THE CIMENTED PROBES; BROKEN PROBE". 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: 1 HOUR TOTAL DELAY; WRONG ROAD IN THE FEMUR. AN ADDITIONAL SURGERY WAS NOT REQUIRED. A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. COPY OF OPERATIVE REPORTS AND X-RAY IMAGES ARE NOT AVAILABLE. PRODUCT IS AVAILABLE FOR RETURN. ON (B)(6) 2021, ORTHOFIX SRL RECEIVED THE FOLLOWING DETAILS FROM THE SALES REPRESENTATIVE: "THE COMPLAINT IS RELATED TO AN OSCAR GENERATOR CODE OS3000 SERIAL NUMBER (B)(4) (MFR REPORT 9680825-2021-00021) AND ONE PIERCER PROBE CODE OHP2062SU BATCH B1387807 (MFR REPORT 9680825-2021-00022). DURING SURGERY, THE PROBE DID NOT RECOGNIZE THE BONE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11670000 ↗