BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PSI SD802.614 PEEK IMPLANT

    MDR report key: 4591585 · Received March 11, 2015

    Report

    Report Number
    2530088-2015-10081
    Event Type
    Injury
    Date Received
    March 11, 2015
    Report Date
    February 25, 2015
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    GXN
    PMA / PMN Number
    PK053199
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    ORIGINALLY REPORTED AS 02/27/15. DEVICE WAS 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

    ADDITIONAL NARRATIVE: CORRECTED DATA, DHR IN REPORT - LOT # REQUESTED WAS 7905503, BUT CONDUCTED ON #7905502. DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE: PART# SD820.614, LOT# 7905503. ACCORDING TO SCANNED DOCUMENTATION IN THE DHR, PSI DEVICE SD802.614 (7905503) WAS MANUFACTURED, ETCHED, INSPECTED, CLEANED AND FORWARD FOR PLASMA TREATMENT AS PER MODEL SPECIFICATIONS SUPPLIED BY CMF PRODUCT DEVELOPMENT ON 26 JANUARY 2015. NO INCONSISTENCIES WERE FOUND DURING THESE PROCESSES. THERE WERE NO NCR¿S ISSUED AGAINST THIS WORK ORDER. DATE OF RELEASE TO WAREHOUSE WAS 26 JANUARY 2015. RAW MATERIAL (LOT# 7749964) ALSO HAD NO ISSUES (NO NCR'S). DEVICE WAS 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

    ADDITIONAL NARRATIVE: INFORMATION RECEIVED ON APRIL 7, 2015: THE SURGEON CALLED TO REPORT THAT THIS PATIENT HAD TRAUMA FROM BIRTH/DELIVERY, WHICH LEAD TO SKULL ISSUES. THIS PATIENT WAS MISSING APPROXIMATELY HALF OF HIS SKULL; IT HAD "MELTED AWAY." SUBSEQUENTLY, PEEK PSI WAS IMPLANTED FOR STRUCTURAL SUPPORT. THE PATIENT HAD SCAPULAR WOUNDS, AND FROM REPEATED RUBBING OF THE HEAD ON THE BED, THE WOUNDS WOULD REOPEN AND WOULD GET INFECTED, THEN THE SHUNT HARDWARE (MANUFACTURER UNKNOWN) BECAME INFECTED. SUBSEQUENTLY, THE PSI AND SHUNT HARDWARE WERE REMOVED. THE DR. CONFIRMED THAT THE INFECTION AND PATIENT'S DEATH WERE NOT RELATED TO SYNTHES DEVICES. NO OTHER ADDITIONAL INFORMATION OR DATE OF DEATH WOULD BE PROVIDED. DEVICE WAS 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. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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

    IT WAS REPORTED THAT TWO PSIS WERE REMOVED DUE TO INFECTION. NO OTHER INFORMATION PROVIDED. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Description of Event or Problem · 1

    UPDATE: IT WAS REPORTED THAT THE ORIGINAL DEVICE WAS IMPLANTED ON (B)(6) 2015. A POSTOPERATIVE INFECTION OCCURRED AND THE IMPLANT AND SHUNT WERE REMOVED ON (B)(6) 2015. A NEW PSI AND SHUNT WERE IMPLANTED DURING THAT SAME REVISION PROCEDURE. THE PATIENT PASSED AWAY A FEW DAYS AFTER THE ORIGINAL IMPLANT WAS REMOVED. IT WAS REPORTED THAT THE PATIENT HAD MANY PRE-EXISTING CONDITIONS NOT RELATED TO THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169340 PSI SD802.614 PEEK IMPLANT PLATE,CRANIOPLASTY,PREFORMED,NONALTERABLE GXN SYNTHES BRANDYWINE 7905503

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention