BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI MATRIXMANDIBLE 20 HOLE RECON PLATE 2.5MM THICK

    MDR report key: 4192670 · Received October 22, 2014

    Report

    Report Number
    3000270450-2014-10125
    Event Type
    Injury
    Date Received
    October 22, 2014
    Report Date
    September 25, 2014
    Manufacturer
    SYNTHES SELZACH
    Product Code
    JEY
    PMA / PMN Number
    PK063790
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THAT THE LOT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMANCES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD DETERMINED THE RAW MATERIAL LOT MET ALL SPECIFICATIONS. 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: AN INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: THE MATRIXMAND RECO-PIATE BROKE BETWEEN THE FOURTH AND FIFTH HOLE LATERAL, POST OPERATIVELY. THERE ARE VARIOUS MECHANICAL DAMAGE ON THE PLATE AS WELL AS ON THE HEX OF THE SCREWS. A LOT OF BONE/TISSUE RESIDUES ON THE PLATE AND ON THE SCREWS WERE VISIBLE. THE MANUFACTURING REVIEW SHOWS THAT THE PRODUCTION PROCEDURE WAS ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THIS DAMAGE WAS CAUSED BY EXPLANTATION OF THE PLATE WITH HIGH PROBABILITY. THE MACROSCOPIC EXAMINATION OF THE FRACTURE SURFACES REVEALED A LOT OF BONE/TISSUE RESIDUES AND MECHANICAL DAMAGE WHICH WERE PRESUMABLY CAUSED BY THE FRAGMENTS CHAFING AGAINST EACH OTHER ON THE FRACTURE SURFACE AFTER BREAKAGE OF THE PLATE. EVEN AFTER INTENSIVE CLEANING OF THE PARTS THE BONE/TISSUE RESIDUES COULD NOT BE REMOVED COMPLETELY. THE MICROSTRUCTURE OF THE USED MATERIAL WAS EXAMINED IN A CROSS SECTION AND FOUND TO BE ACCORDING TO THE STANDARDS. THERE WERE NO EVIDENT IRREGULARITIES (I .E. NONMETALLIC INCLUSIONS ETC) OR SIGNS OF EMBRITTLEMENT. THE PERFORMED INVESTIGATION COULD NOT DETECT ANY MATERIAL FAULTS. THE MATRIXMAND RECO-PIATE IN QUESTION HAS BECOME MOST PRESUMABLY FATIGUED DUE TO CYCLIC LOADING. THE MACROSCOPIC DISCERNABLE FINE FATIGUE LINES AND SECONDARY CRACKS ON THE REMAINING ORIGINAL FRACTURE FACE ARE A SIGN OF A FATIGUE CRACK UNDER CYCLIC OVERLOAD. THE FRACTURE BEHAVIOR IS DUE TO MISSING MACROSCOPIC FATIGUE STRIATIONS AND RESIDUAL FRACTURE UNREPRODUCIBLE. THE REASON FOR THE DAMAGE TO THE PLATE COULD NOT BE DETERMINED WITH ACCURACY. 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: A PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: THE PLATE WAS RECEIVED IN TWO PIECES. THE TWO PIECES OF THE PLATE WERE EVALUATED. EVIDENCE THAT THE TWO PIECES ORIGINATED FROM THE SAME DEVICE WAS CONFIRMED BY ALIGNMENT OF THE FRACTURE LINE. THE TWO PIECES ALIGNED ALONG A CONTIGUOUS AND IRREGULAR EDGE. ONE PIECE WAS NOTED TO CONSIST OF A 14-HOLE SEGMENT; THE OTHER PIECE HAD 4-HOLE SEGMENTS PRESENT. THE PLATE PIECES SHOWED SIGNS OF RED-BROWN DISCOLORATION. ONE END OF THE 14-HOLE SEGMENT WAS CUT AND HAD EVIDENCE OF BEING DE-BURRED WHICH IS A TYPICAL OCCURRENCE. THE OTHER END OF THE 14-HOLE SEGMENT REVEALED A FRACTURE. IT WAS DETERMINED THE PLATE WAS BENT WITH THE LAST HOLD BEND FEATURE OF THE 03.503.056 INSTRUMENT. BASED ON SMALL INDENTATION EVIDENT ON THE DEVICE, IT IS LIKELY THERE WAS ALSO REVERSE BENDING, BUT THIS COULD NOT BE VERIFIED. ACCORDING TO THE SURGICAL TECHNIQUE, THIS BENDING FEATURE IS TO BE USED ONLY TO BEND THE LAST HOLE SEGMENT OF A PLATE, AND NOT THE SEGMENTS ALONG THE LENGTH OF THE PLATE WHICH IS SUSPECTED TO HAVE OCCURRED IN THIS PLATE COMPLAINT INDICATED BY THE SMALL INDENTATIONS ON THE TOP AND BOTTOM SURFACES. THE PLATE WAS NOTED TO BE BENT IN THE OUT-OF-PLANE DIRECTION ONLY. THE PLATE DID NOT SHOW EVIDENCE OF ANY IN-PLANE BENDING AS ALL HOLE SEGMENTS WERE IN VISIBLE CONTACT WITH A FLAT SURFACE ON WHICH IT WAS PLACED. THE PLATE SHOWED LITTLE TO NO EVIDENCE OF TWISTING. THE SMALL INDENTATIONS ON THE TOP AND BOTTOM SURFACES AIDE IN THE DETERMINATION OF THE ORIENTATION OF THE BENDING INSTRUMENT (03.503.056) WHICH PROVIDES A 3-POINT BEND. THERE IS EVIDENCE OF THE USE OF THE LAST HOLE BEND FEATURE OF THE MATRIXMANDIBLE BENDER (03.503.056) BEING USED ALONG THE LENGTH OF THE PLATE RATHER THAN THE LAST HOLE OF THE PLATE AS DESCRIBED IN THE SURGICAL TECHNIQUE GUIDE. THERE IS NO EVIDENCE OF REVERSE BENDS HAVING BEEN PERFORMED AT THE FRACTURE SITE IN THE PLATE. THE ROOT CAUSE OF THE PLATE FRACTURE IS INDETERMINATE. 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: MANUFACTURING EVALUATION: THE MATRIXMAND RECO-PLATE IN QUESTION HAS BECOME MOST PRESUMABLY FATIGUED DUE TO CYCLIC LOADING. THE MACROSCOPIC DISCERNABLE FINE FATIGUE LINES AND SECONDARY CRACKS ON THE REMAINING ORIGINAL FRACTURE FACE ARE A SIGN OF A FATIGUE CRACK UNDER CYCLIC OVERLOAD. THE FRACTURE BEHAVIOR IS DUE TO MISSING MACROSCOPIC FATIGUE STRIATIONS AND RESIDUAL FRACTURE UNREPRODUCIBLE. THE PERFORMED INVESTIGATION COULD NOT DETECT ANY MATERIAL FAULTS: MACROSCOPIC EXAMINATION OF THE IMPLANT; FRACTOGRAPHIC EXAMINATION OF THE LOCKING SCREW PIN; ELECTRON MICROSCOPIC EXAMINATION OF THE LOCKING SCREW PIN; METALLOGRAPHIC EXAMINATION OF THE MATERIAL; HARDNESS MEASUREMENT OF THE MATERIAL. THE REASON FOR THE DAMAGE TO THE PLATE COULD NOT BE DETERMINED WITH ACCURACY. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PLATE WAS IMPLANTED IN PATIENT ON (B)(6) 2014. IN (B)(6), THE PATIENT HEARD ABNORMAL NOISES AND FELT SOMETHING WRONG WITH THE JAW (PLATE) WHEN HE/SHE WAS EATING SNACKS. WHEN THE PATIENT SAW A DOCTOR AFTER THIS EVENT, IT WAS CONFIRMED THAT THE PLATE WAS BROKE, A REPLACEMENT WAS CONDUCTED IN SEPTEMBER. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673325 TI MATRIXMANDIBLE 20 HOLE RECON PLATE 2.5MM THICK BONE PLATE JEY SYNTHES SELZACH 8446452

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention