BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROI-C SHORT ANCHORING PLATE

    MDR report key: 7497633 · Received May 9, 2018

    Report

    Report Number
    3004788213-2018-00143
    Event Type
    Injury
    Date Received
    May 9, 2018
    Date of Event
    April 11, 2018
    Report Date
    May 4, 2020
    Manufacturer
    LDR MÉDICAL
    Product Code
    OVE
    PMA / PMN Number
    K151934
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    D4 LOT NUMBER: 283556/4 OR 283308/9. D4 UDI NUMBER: (B)(4) OR (B)(4). H4 MFG DATE: AUG 23, 2017 OR AUG 28, 2017. CORRECTION TO: A1, A2 (AGE), B1, B2, B5, B6, B7, D1, D2 (COMMON DEVICE NAME), E1, E2, E3, G3, H3, H4, H6 (PATIENT CODES). ADDITIONAL INFORMATION: A5, D4 (LOT NUMBER AND UDI NUMBER), G5 (PMA/510K), H6 (DEVICE, METHOD, RESULTS AND CONCLUSION CODES). THE PLATE WAS NOT RETURNED FOR EVALUATION, SO NO RESULTS ARE AVAILABLE AND NO CONCLUSIONS CAN BE DRAWN. THE LOT NUMBER IS UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. THE SURGICAL TECHNIQUE GUIDE WAS REVIEWED AND FOUND TO CONTAIN ADEQUATE LANGUAGE REGARDING PLATE INSTALLATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONE CAGE BROKE AND A PLATE BENT DURING INSERTION. NO FOREIGN BODIES WERE RETAINED BY THE PATIENT. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES. NO PATIENT HARM WAS REPORTED. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED TO MANUFACTURER. AS IT WAS DISCARDED BY THE HOSPITAL NO EXAMINATION CAN BE PERFORMED. THE REVIEW OF THE TRACEABILITY AND DEVICE HISTORY RECORDS DID NOT REVEAL ANY NON-CONFORMANCES TO SPECIFICATIONS OR DEVIATIONS IN PROCEDURES THAT MIGHT HAVE CONTRIBUTED TO THE REPORTED EVENT. ADDITIONAL INFORMATION WERE REQUESTED TO THE REPORTER . CONCLUSION IS NOT YET AVAILABLE. INVESTIGATION STILL IN PROGRESS. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    ROI-C : BROKEN IMPLANT UPON ANCHOR IMPACTION. DESCRIPTION PROVIDED IN THE COMPLAINT REPORT : FIRST IMPLANT BROKE UPON FINAL IMPACT. REPORTER DON'T INDICATE ANY HARM OR INJURY TO THE PATIENT. REPORTER DON'T MENTION ANY SURGERY COMPLICATION. THE SURGERY WAS DELAY 35 MINUTES. NO INFORMATION WERE GIVEN ABOUT THE EXACT LOT NUMBER OF THE ANCHORING PLATE ASSOCIATED TO THIS EVENT. ANOTHER REPORT WAS ALSO SENT CONCERNING THE OTHER ANCHORING PLATE LOT NUMBER. ADDITIONAL INFORMATION WERE REQUESTED. INVESTIGATION STILL IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341347 ROI-C SHORT ANCHORING PLATE ROI-C TITANIUM-COATED IMPLANT SYSTEM OVE LDR MÉDICAL N/A SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other