BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI LUMBAR EXTENSION SIZE 7/220MM RADIUS

    MDR report key: 6616757 · Received June 6, 2017

    Report

    Report Number
    2530088-2017-10178
    Event Type
    Injury
    Date Received
    June 6, 2017
    Report Date
    May 10, 2017
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MDI
    UDI-DI
    07611819747340
    PMA / PMN Number
    K142587
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BRAND NAME CORRECTION. DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT ID & DOB NOT PROVIDED FOR REPORTING. NOT EXPLANTED. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). (B)(4). THE REPORTED EVENT REQUIRED MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE. SHOULD FURTHER INFORMATION BECOME AVAILABLE THIS DETERMINATION WILL BE REVIEWED ACCORDINGLY. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: PART 497.132 / 6002159, MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 13-FEB-2009. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT SUFFERS FROM PROGRESSIVE SCOLIOSIS WITH EXCESSIVE THORACIC DEFORMITY (PRIMARY DISEASE: SOTOS SYNDROME). (B)(6) 2012 THE FOLLOWING TWO STABILIZATIONS WERE PERFORMED. HYBRID TYPE VEPTR (SIZE 9) WAS APPLIED, RANGING FROM THE RIGHT 2ND LIB TO THE ILEUM. HYBRID TYPE VEPTR (SIZE 7) WAS APPLIED, RANGING FROM THE RIGHT 3RD LIB TO THE 2ND LUMBAR SPINE. (B)(6) 2012 THE POST-OPERATIVE INFECTION ON THE WOUNDED ARE WAS CONFIRMED. (B)(6) 2012 A NECESSARY TREATMENT (UNKNOWN TREATMENT DETAILS) WAS PERFORMED. THE PATIENT BECAME WELL. (B)(6) 2013, AND (B)(6) 2014, THE SURGERIES FOR ADJUSTING VEPTR SIZE WAS PERFORMED ON RESPECTIVE DATES. (B)(6) 2014 THE SURGERY FOR ADJUSTING VEPTR SIZE WAS PERFORMED. SUPERIOR MESENTERIC ARTERY SYNDROME WAS NOTICED AGAIN (B)(6) 2014, HOWEVER, THE PATIENT GRADUALLY BECAME WELL. (B)(6) 2014 IT WAS REPORTED THAT THE PATIENT HAS RECOVERED. THIS COMPLAINT INVOLVES 16 PARTS. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397718 TI LUMBAR EXTENSION SIZE 7/220MM RADIUS PROSTHESIS, RIB REPLACEMENT MDI SYNTHES BRANDYWINE 6002159 07611819747340

    Patients

    Seq Age Sex Outcome Treatment
    1 26 MO Required Intervention