BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/65MM

    MDR report key: 5039215 · Received August 28, 2015

    Report

    Report Number
    1000562954-2015-10174
    Event Type
    Injury
    Date Received
    August 28, 2015
    Report Date
    August 14, 2015
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    JDP
    PMA / PMN Number
    PK110354
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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

    THIS REPORT IS FOR ELEVEN (11) INTACT SCREWS. THE FOLLOWING INFORMATION IS THE BREAKDOWN OF THESE PARTS. PART 02.231.270 / LOT 9225222 - 5.0MM VARIABLE ANGLE LOCKING SCREW/SLF-TPNG/STRDRV/70MM ¿ JDP, HRS, HWC -- K110354 PART 02.231.285 / LOT 9236088 - 5.0MM VARIABLE ANGLE LOCKING SCREW/SLF-TPNG/STRDRV/85MM ¿ JDP, HRS, HWC -- K110354 PART 02.231.238 / LOT 8820507 - 5.0MM VARIABLE ANGLE LOCKING SCREW/SLF-TPNG/STRDRV/38MM ¿ JDP, HRS, HWC -- K110354 PART 02.231.238 / LOT 9179043 - 5.0MM VARIABLE ANGLE LOCKING SCREW/SLF-TPNG/STRDRV/38MM ¿ JDP, HRS, HWC -- K110354 PART 02.231.230 / LOT 7572844 - 5.0MM VARIABLE ANGLE LOCKING SCREW/SLF-TPNG/STRDRV/30MM ¿ JDP, HRS, HWC -- K110354 PART 02.231.275 / LOT 9225196 - 5.0MM VARIABLE ANGLE LOCKING SCREW/SLF-TPNG/STRDRV/75MM ¿ JDP, HRS, HWC -- K110354 PART 02.231.280 / LOT 9179037 - 5.0MM VARIABLE ANGLE LOCKING SCREW/SLF-TPNG/STRDRV/80MM ¿ JDP, HRS, HWC -- K110354 PART 02.231.240 / LOT 8844172 - 5.0MM VARIABLE ANGLE LOCKING SCREW/SLF-TPNG/STRDRV/40MM ¿ JDP, HRS, HWC -- K110354 PART 02.231.244 / LOT 9044038 - 5.0MM VARIABLE ANGLE LOCKING SCREW/SLF-TPNG/STRDRV/44MM ¿ JDP, HRS, HWC -- K110354. (B)(6) (B)(4) SUBJECT DEVICE HAS BEEN RECEIVED; NO CONCLUSIONS COULD BE DRAWN AS THE DEVICE IS ENTERING THE COMPLAINT SYSTEM. DEVICE HISTORY REVIEW: A REVIEW OF THE DHRS FOR ALL OF THE INTACT SCREWS REVEALED THE FOLLOWING: 02.231.270 / 9225222 MANUFACTURING LOCATION: (B)(4) - MANUFACTURING DATE: OCTOBER 31, 2014. 02.231.285 / 9236088 MANUFACTURING LOCATION: (B)(4) - MANUFACTURING LOCATION: (B)(4) - MANUFACTURING DATE: OCTOBER 6, 2014. 02.231.230 / 7572844 MANUFACTURING LOCATION: (B)(4) - MANUFACTURING DATE: AUGUST 31, 2011. 02.231.275 / 9225196 MANUFACTURING LOCATION: (B)(4) - MANUFACTURING DATE: OCTOBER 31, 2014. 02.231.280 / 9179037 MANUFACTURING LOCATION: (B)(4) - MANUFACTURING DATE: OCTOBER 3, 2014. 02.231.238 / 8820507 MANUFACTURING LOCATION: (B)(4) - MANUFACTURING DATE: JANUARY 29, 2014. 02.231.240 / 8844172 MANUFACTURING LOCATION: (B)(4) - MANUFACTURING DATE: FEBRUARY 11, 2014 02.231.244 / 9044038 MANUFACTURING LOCATION: (B)(4) - MANUFACTURING DATE: JULY 1, 2014. NO NON-CONFORMANCE REPORTS 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. 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. ADDITIONAL NARRATIVE: THE ELEVEN 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV DEVICES WERE VISUALLY INSPECTED AND WERE RECEIVED INTACT; THEREFORE, NO FURTHER EVALUATION WAS PERFORMED FOR THESE DEVICES AS NO COMPLAINT WAS ALLEGED AGAINST THEM. THESE DEVICES COULD NOT BE DISASSOCIATED FROM THE REPORTED ADVERSE EVENT; HOWEVER, BASED ON THE PREVIOUSLY REPORTED DEVICE HISTORY RECORD REVIEW FINDINGS OF NO MANUFACTURING RELATED ISSUES IDENTIFIED AND THE RECEIVED CONDITION OF INTACT, NO FURTHER INVESTIGATION WAS DEEMED NECESSARY. NO PRODUCT FAULT COULD BE IDENTIFIED. INFORMATION SUBMITTED IN MEDWATCH FOLLOW-UP #1 WAS INCORRECT. ELEVEN SCREWS OF VARYING LENGTHS FROM PRODUCT FAMILY (B)(4) WERE REPORTED AND RECEIVED AS REPORTED IN THE INITIAL MEDWATCH REPORT. PARTIAL BRAND NAME IS: 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV. 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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT AN IMPLANT BROKE POST-OPERATIVELY. THE PATIENT WAS ORIGINALLY IMPLANTED WITH A VARIABLE-ANGLE LOCKING COMPRESSION (VA-LCP) CONDYLAR PLATE ON (B)(6) 2015. SOMETIME THEREAFTER, THE DEVICE BROKE. THE PATIENT HAD A BONE DEFICIT OF 8.6CM AND THE BONE GRAFT DID NOT GIVE ENOUGH SUPPORT TO THE IMPLANT. IN ADDITION, THE PATIENT WAS PERMITTED FULL WEIGHT BEARING (NOT LOAD SHARING) AFTER SIX (6) WEEKS. THE BROKEN IMPLANT AND INTACT SCREWS WERE REMOVED DURING AN EXPLANT PROCEDURE ON (B)(6) 2015. AT THIS TIME, THE SURGEON USED THE HOFFMAN METHOD AND PLANNED FOR NAILING AT A LATER DATE. THIS REPORT IS FOR ELEVEN (11) INTACT SCREWS. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571785 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/65MM IMPLANT, FIXATION DEVICE, CONDYLAR PLATE JDP SYNTHES MEZZOVICO

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention