BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RESPONSE 6.0 COCR ROD

    MDR report key: 9753139 · Received February 26, 2020

    Report

    Report Number
    3006460162-2019-00085
    Event Type
    Injury
    Date Received
    February 26, 2020
    Date of Event
    November 6, 2019
    Report Date
    February 25, 2020
    Manufacturer
    ORTHOPEDIATRICS, CORP
    Product Code
    KWP
    PMA / PMN Number
    K150600
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOW IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CORRECTION: A4: 107 KG. UPDATED: H6 UPDATED METHOD 4119 AND 4114. H6 UPDATED RESULTS 3207. H6 UPDATED CONCLUSION 4315. COMPLAINT SAMPLE WAS NOT RETURNED FOR EVALUATION. DHR REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE INVOLVED DEVICE IS UNKNOWN. THERE WERE NO RECENT DESIGN CHANGES PRIOR TO MANUFACTURING. RISK MANAGEMENT FILE REVIEW WAS DEEMED APPROPRIATE. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCT: ITEM NUMBER: 00-1003-4001, RESPONSE LARGE SET SCREW, LOT NUMBER: M56976-B; ITEM NUMBER: 00-1003-4001, RESPONSE LARGE SET SCREW, LOT NUMBER: M55906-A; ITEM NUMBER: 00-1300-0745, RESPONSE 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 45MM, LOT NUMBER: 042938-E; ITEM NUMBER: 00-1300-0745, RESPONSE 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 45MM, LOT NUMBER: 041824-E; ITEM NUMBER: UNKNOWN, UNKNOWN RESPONSE 6.0 COCR ROD, LOT NUMBER: UNKNOWN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3006460612-2019-00084, 3006460612-2019-00086, AND 3006460612-2019-00087.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT FOLLOWING THE PLACEMENT OF A RESPONSE SPINAL CONSTRUCT, THE PATIENT UNDERWENT A REVISION DUE TO ROD FRACTURE AND DISENGAGEMENT. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219232 UNKNOWN RESPONSE 6.0 COCR ROD APPLIANCE, FIXATION, SPINAL INTERLAMINAL, KWP ORTHOPEDIATRICS, CORP N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention