BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYMETHYLMETHACRYLATE BONE CEMENT

    MDR report key: 5879462 · Received August 16, 2016

    Report

    Report Number
    2520274-2016-14122
    Event Type
    Injury
    Date Received
    August 16, 2016
    Date of Event
    July 28, 2016
    Report Date
    July 29, 2016
    Manufacturer
    SYNTHES SELZACH
    Product Code
    NDN
    PMA / PMN Number
    K130146
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. THIS REPORT IS FOR ONE (1) UNKNOWN SYNFLATE BALLOON. ADDITIONAL PRODUCT CODES FOR THIS REPORT INCLUDE HRX. WITHOUT A VALID PART AND LOT NUMBER, THE UDI IS NOT AVAILABLE. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED OR EXPLANTED. THE COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). SYNFLATE VERTREBAL BALLOONS HAVE BEEN ASSIGNED A 510K OF K130146. HOWEVER, WITHOUT VERIFICATION OF THE EXACT PART NUMBER, THIS CANNOT BE CONFIRMED. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW COULD NOT BE REQUESTED. 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

    MANUFACTURING INVESTIGATION COMPLETED FOR PART NUMBER 03.804.700S, LOT NUMBER 0116030. THE REVIEW OF THE MANUFACTURING HISTORY OF THE PRODUCTION LOT DID NOT REVEAL ANY NONCONFORMITY. THE COMPLAINT INSTRUMENT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND SUCCESSFULLY PASSED ALL IN-PROCESS INSPECTIONS AS WELL AS THE FINAL INSPECTION. THE COMPLAINT INSTRUMENT WAS FRACTURED PROXIMAL TO THE PROXIMAL BALLOON WELD. THE TUBING WAS PLASTICALLY DEFORMED AND ELONGATED NEAR THE FRACTURE SURFACE, INDICATING THAT THE FRACTURE OCCURRED DUE TO TENSILE OVERLOAD. IT APPEARS THAT THE BALLOON BECAME STUCK AT THE DISTAL END OF THE WORKING SLEEVE. SINCE THE DISTAL FRAGMENT INCLUDING THE BALLOON REMAINED INSIDE THE PATIENT IT WAS NOT POSSIBLE TO DETERMINE WHY THE BALLOON WAS STUCK (E.G. INSUFFICIENT DEFLATION, UNABLE TO HOLD VACUUM DUE TO LEAKAGE). THE TUBING WAS PLASTICALLY DEFORMED AND ELONGATED NEAR THE FRACTURE SURFACE, INDICATING THAT THE FRACTURE OCCURRED DUE TO TENSILE OVERLOAD. (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

    DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: DHR REVIEW FOR: PART: 03.804.700S LOT: 0116030 MANUFACTURING LOCATION: (B)(4), LEGAL MANUFACTURER: EXTERNAL SUPPLIER (B)(4). MANUFACTURING DATE: 19.APR.2016 EXPIRY DATE: 01.FEB.2018. 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. SYNTHES MANUFACTURING LOCATION WAS DISCOVERED UPON RECEIPT OF SUBJECT DEVICE. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2016 THAT REQUIRED THE USE OF A SYNFLATE BALLOON. DURING THE PROCEDURE, THE BALLOON REPORTEDLY WENT OFF OF THE SHAFT WITHOUT MUCH FORCE FROM THE USER. IT WAS NOTED THAT THE BALLOON WAS RETAINED IN THE PATIENT; HOWEVER, IT WAS FURTHER REPORTED THAT THE DEVICE WOULD BE AVAILABLE FOR RETURN. AT THIS TIME, IT IS UNKNOWN IF THE BALLOON BURST WITH ONLY A PORTION LEFT IN SITU, OR IF ANOTHER ISSUE OCCURRED THAT RESULTED IN FULL RETENTION OF THE BALLOON. THE PROCEDURE WAS COMPLETED WITH A TEN (10) MINUTE DELAY. THIS REPORT IS FOR ONE (1) UNKNOWN SYNFLATE BALLOON. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530674 POLYMETHYLMETHACRYLATE BONE CEMENT NDN SYNTHES SELZACH 0116030

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention