BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESPONSE 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 45MM

    MDR report key: 9756062 · Received February 26, 2020

    Report

    Report Number
    3006460162-2019-00086
    Event Type
    Injury
    Date Received
    February 26, 2020
    Date of Event
    November 6, 2019
    Report Date
    February 26, 2020
    Manufacturer
    ORTHOPEDIATRICS, CORP
    Product Code
    OSH
    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: H4 UPDATED 05 JUN 2015. H6 UPDATED METHOD 3331, 4109 AND 10. H6 UPDATED RESULTS 140. H6 UPDATED CONCLUSION 4315. COMPLAINT SAMPLE WAS RETURNED FOR EVALUATION. THE COMPLAINT WAS CONFIRMED. DHR REVIEW: PRODUCT AND PROCESS SHOW CONFORMING. 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

    REFERENCE: (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: 041824-E, ITEM NUMBER: UNKNOWN, UNKNOWN RESPONSE 6.0 COCR ROD, LOT NUMBER: UNKNOWN, 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, 3006460612-2019-00085, 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. DURING THE REVISION IT WAS NOTED THAT TWO PEDICLE SCREWS WERE REPLACED DUE TO WEAR. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221012 RESPONSE 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 45MM PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS OSH ORTHOPEDIATRICS, CORP N/A 042938-E

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention