BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DCP 4.5-BROAD 11HO L183 SST

    MDR report key: 6352836 · Received February 23, 2017

    Report

    Report Number
    3009450884-2017-10026
    Event Type
    Injury
    Date Received
    February 23, 2017
    Report Date
    January 31, 2017
    Manufacturer
    SYNTHES GRENCHEN
    Product Code
    HRS
    UDI-DI
    07611819006133
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: UNKNOWN IF DEVICE WAS ALREADY BROKEN. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). THE 510K#UNKNOWN. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: PART # 226.110 / LOT # 9047379. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 01 JULY 2014. 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. PART# REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS 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.

    Additional Manufacturer Narrative · 1

    THE GIVEN INFORMATION ON THE DEVICE REPORT HAS INDICATED THAT THE DYNAMIC COMPRESSION PLATE (DCP) WAS NOT SUITABLE FOR THE SIZE OF THE BONE AND IT WAS PLACED IN THE WRONG WAY. UNFORTUNATELY THE COMPLAINED ITEM WAS NOT RETURNED FOR EVALUATION. WITHOUT HAVING THE MATERIAL WE CANNOT GIVE A CONCLUSIVE STATEMENT REGARDING THE POSSIBLE FAILURE REASON. NO FURTHER INFORMATION HAD BEEN MADE AVAILABLE THEREFORE AN INVESTIGATION COULD NOT BE PERFORMED. THIS PARTICULAR ITEM WAS PRODUCED IN DECEMBER 2013 ACCORDING TO THE SPECIFICATION. THE REVIEW OF THE X-RAYS CAN BE CONFIRMED REGARDING THE BROKEN PLATE. PRODUCT WAS NOT RETURNED THEREFORE AN INVESTIGATION COULD NOT BE PERFORMED. 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

    THE REVIEW OF THE X-RAYS CAN BE CONFIRMED FOR THE BROKEN PLATE AND NOT FOR THE PLATE WHICH WAS NOT SUITABLE FOR THE SIZE OF THE BONE. 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

    (B)(4). 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 ON AN EVENT IN (B)(6) AS FOLLOWS: THE PATIENT NEEDED A REVISION SURGERY AND DYNAMIC COMPRESSION PLATE (DCP) AND SCREWS WERE IMPLANTED ON (B)(6) 2014. HOWEVER, AFTER A FEW MONTHS THE PATIENT NOTICED THAT THE FRACTURE DID NOT IMPROVE. WHEN CHECKING WITH A THIRD SURGEON IT WAS SEEN THAT THE DCP WAS NOT SUITABLE FOR THE SIZE OF THE BONE AND THAT IT WAS PLACED IN THE WRONG WAY. NO INFORMATION AVAILABLE ABOUT PATIENT CONDITION, OUTCOME AND IF A REVISION SURGERY WAS PERFORMED OR NOT. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2015 TO REMOVE THE PLATE. PATIENT OUTCOME IS GOOD. THIS COMPLAINT INVOLVES 1 PART. CONCOMITANT REPORTED PARTS: 1X CORTEX SCREW (PART 214.038 LOT 8993815); 1X CORTEX SCREW (PART 214.040 LOT 8916335); 1X CORTEX SCREW (PART 214.042 LOT 8794952); 1X CORTEX SCREW (PART 214.044 LOT 8821516). THIS REPORT IS 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    SEVERAL MONTHS AFTER THE FIRST REVISION SURGERY PATIENT NOTICED THAT THE FRACTURE WAS NOT HEALING AND PATIENT¿S LEFT LEG WAS CROOKED, COULD NOT SUPPORT IT ON THE GROUND, AND NEEDED TO USE CRUTCHES TO MOVE AROUND. PATIENT REVISED AGAIN ON (B)(6) 2015. AS A RESULT OF SO MANY SURGICAL OPERATIONS, THE PLAINTIFF¿S LEG HAD BEEN SHORTENED BY APPROXIMATELY 1.5 CM. FIRST REVISION SURGERY PERFORMED ON (B)(6) 2014 DUE TO POSTOPERATIVE PLATE BREAKAGE HAS BEEN ADDRESSED IN THE LINKED COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136069 DCP 4.5-BROAD 11HO L183 SST PLATE, FIXATION, BONE HRS SYNTHES GRENCHEN 9047379 07611819006133

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention 1X CORTEX SCREW (PART 214.038 LOT 8993815)| 1X CORTEX SCREW (PART 214.040 LOT 8916335)| 1X CORTEX SCREW (PART 214.042 LOT 8794952)| 1X CORTEX SCREW (PART 214.044 LOT 8821516)