BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDICLE SCREW ROD COCR 5.5X480

    MDR report key: 7685636 · Received July 13, 2018

    Report

    Report Number
    3005180920-2018-00501
    Event Type
    Injury
    Date Received
    July 13, 2018
    Date of Event
    June 13, 2018
    Report Date
    July 13, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWP
    UDI-DI
    07630030835445
    PMA / PMN Number
    K121115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 09 JULY 2018. LOT 144216B: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22 NOVEMBER 2017. EXPIRATION DATE: 2022-10-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. OTHER DEVICE INVOLVED: PEDICLE SCREW REFERENCE 03.50.433 (K121115) ROD COCR 5.5X480. LOT 148723: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08 MAY 2017. EXPIRATION DATE: 2022-04-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR ON 10 JULY 2018: IN A LONG POSTERIOR THORACO-LUMBAR STABILIZATION (DIAGNOSIS UNKNOWN, BUT IT IS LIKELY TO BE A DEFORMITY CASE) BOTH COCR RODS FRACTURED AT L5-S1 ONLY FEW WEEKS AFTER SURGERY. THE CAUSE FOR SUCH FRACTURE IS TOTALLY UNKNOWN; NO TRAUMAS HAVE BEEN REPORTED BUT THE DOUBLE FRACTURE AT THE SAME LEVEL LEADS TO SUSPECT THAT AN ABNORMAL LOAD WAS SUFFERED BY THE CONSTRUCT. AT SUCH SHORT FOLLOW UP TIME IT SHOULD BE A FATIGUE FRACTURE. NO CLINICAL CAUSE FOR THIS EVENT CAN BE DETERMINED WITH THE INFORMATION AT HAND.

    Description of Event or Problem · 1

    THE ROD SNAPPED INSIDE THE PATIENT. IT IS UNKNOWN HOW THE ROD SNAPPED. IT IS UNKNOWN WHEN THE REVISION WILL TAKE PLACE. THE SURGEON DID NOT PERFORM AN OSTEOTOMY. THE PATIENT HAD SIGNIFICANT BLOOD LOSS AND THIS WAS THEIR 3RD SURGERY. THAT MAY HAVE FACTORED INTO THAT DECISION. NO CAGE SUBSIDENCE OR FRACTURE WAS MENTIONED. PATIENT WILL BE REVISED WITH COMPETITOR'S IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529206 PEDICLE SCREW ROD COCR 5.5X480 ROD COCR KWP MEDACTA INTERNATIONAL SA 144216B 07630030835445

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention