BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODISC-C IMPLANT LARGE DEEP 5MM-STERILE

    MDR report key: 5348641 · Received January 6, 2016

    Report

    Report Number
    1719045-2016-10025
    Event Type
    Injury
    Date Received
    January 6, 2016
    Report Date
    December 17, 2015
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    PP070001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. PART 09.820.055S, LOT# 7077027 DID NOT CONTAIN ANY NON-CONFORMANCE REPORTS (NCRS) OR ANOMALIES. (B)(4) PCS ACCEPTED/CONFORMING. IN ADDITION, THE FOLLOWING LOTS WERE REVIEWED: 7200259, 7200225, 7238436, 5808582 (RM), 6413529 (RM). PART 09.820.055.1, LOT # 7200259 DID NOT CONTAIN ANY NCRS. (B)(4) WERE CONFORMING/RELEASED FROM HOLD. SUB-COMPONENT PRODUCT LOT UNDERWENT ALL SPECIFIED INSPECTION REQUIREMENTS WITH NO PRODUCT NONCONFORMITIES REPORTED. DHR RECORDS INCLUDE AN INCOMING DEFECT REPORT (B)(4) FROM THE PLASMA SPRAY SURFACE FINISH SUPPLIER INDICATING THAT ALL PARTS WITHIN THE LOT EXHIBITED SCRATCHES AND NICKS PRIOR TO PLASMA SPRAY. THE IDR INDICATES THAT THE PARTS WERE PROCESSED AS NORMAL. SUBSEQUENT INCOMING INSPECTION OF THE PARTS FOLLOWING PLASMA SPRAY OPERATIONS INDICATE THAT FINISHED PARTS MET ALL SPECIFIED CRITERION FOR ACCEPTANCE. THERE IS NO INDICATION THAT THE OBSERVED SCRATCHES REPORTED BY IDR (B)(4) ARE RELEVANT TO THE COMPLAINT CONDITION REPORTED. PART 09.820.055.2, LOT # 7200225 DID NOT CONTAIN ANY NCRS. (B)(4) WERE CONFORMING/RELEASE FROM HOLD. SUB-COMPONENT PRODUCT LOT UNDERWENT ALL SPECIFIED INSPECTION REQUIREMENTS WITH NO PRODUCT NONCONFORMITIES REPORTED. DHR RECORDS INCLUDE AN INCOMING DEFECT REPORT (IDR) (B)(4) FROM THE PLASMA SPRAY SURFACE FINISH SUPPLIER INDICATING THAT ALL PARTS WITHIN THE LOT EXHIBITED NICKS AND SCRATCHES PRIOR TO PLASMA SPRAY. THE IDR INDICATES THAT THE PARTS WERE PROCESSED AS NORMAL. SUBSEQUENT INCOMING INSPECTION OF THE PARTS FOLLOWING PLASMA SPRAY OPERATIONS INDICATE THAT FINISHED PARTS MET ALL SPECIFIED CRITERION FOR ACCEPTANCE. THERE IS NO INDICATION THAT THE OBSERVED SCRATCHES REPORTED BY IDR (B)(4) ARE RELEVANT TO THE COMPLAINT CONDITION REPORTED. PART 09.820.055.3, LOT # 7238436 DID NOT CONTAIN ANY NCRS OR ANY ANOMALIES. TOTAL LOT PCS WERE (B)(4), ALL (B)(4) WERE ACCEPTED/CONFORMING. DHR RECORDS FOR RAW MATERIAL COCRMORI25.00, P/N 41041, LOT# 5808582 INDICATE THAT THE RAW MATERIAL WAS RECEIVED AT THE (B)(4) FACILITY ON 08/01/2008. DHR RECORDS FOR THE RAW MATERIAL LOT FURTHER INDICATE THAT THE RAW MATERIAL UNDERWENT ALL REQUIRED INSPECTION AND TEST REQUIREMENTS WITH NO NONCONFORMITIES REPORTED. DHR RECORDS FOR RAW MATERIAL UHMWPERI25.00, P/N 41042, LOT# 6413529 INDICATE THAT THE RAW MATERIAL WAS RECEIVED AT THE (B)(4) FACILITY ON 6/11/10. DHR RECORDS FOR THE RAW MATERIAL LOT FURTHER INDICATE THAT THE RAW MATERIAL UNDERWENT ALL REQUIRED INSPECTION AND TEST REQUIREMENTS WITH NO NONCONFORMITIES REPORTED. 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. (B)(6). THIS REPORT IS FOR ONE UNKNOWN PRODISC-C IMPLANT. PART AND LOT NUMBERS WERE NOT PROVIDED BY THE REPORTER. THE DATE OF IMPLANT IS AN UNKNOWN DATE IN 2013. THE SUBJECT DEVICE IS EXPECTED TO BE RETURNED TO THE SYNTHES MANUFACTURER FOR EVALUATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    SYNTHES MANUFACTURING LOCATION WAS CORRECTED TO (B)(4). 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

    A MANUFACTURING EVALUATION WAS COMPLETED: THE REPORTED PRODUCT WAS RETURNED AS TWO PIECES: THE INFERIOR PLATE AND SUPERIOR PLATE; THE INLAY COMPONENT HAS BEEN REMOVED FROM ITS NORMALLY ASSEMBLED CONDITION AND WAS NOT RETURNED. THE RETURNED DEVICE EXHIBIT VISIBLE DISCOLORATION AND SCRATCHES WHICH IS INDICATIVE OF POST MANUFACTURING DAMAGE OR USE. IN REGARDS TO THE COMPLAINT (PATIENT EXPERIENCING PAIN), THERE ARE NO RELATED DIMENSIONAL FEATURES WHICH CAN BE ASSOCIATED WITH THE CONDITION. MACHINED DIMENSIONS CANNOT BE CHECKED ON THE SUPERIOR AND INFERIOR PLATES DUE TO THE PLASMA COATING. POST PLASMA COATED SURFACES WILL PREVENT ACCURATE LOCATION AND COULD DAMAGE THE CMM PROBE TIPS. THE SUPERIOR AND INFERIOR PLATE MACHINING DIMENSIONS ARE NORMALLY INSPECTED 100% USING A CMM PRIOR TO PLASMA COATING. THEREFORE, THE COMPLAINT IS UNCONFIRMED. A PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: ONLY THE SUPERIOR AND INFERIOR ENDPLATES WERE RETURNED FOR ANALYSIS. THE SUPERIOR ENDPLATE EXHIBITED IATROGENIC DAMAGE. NO DESIGN RELATED ISSUES COULD BE IDENTIFIED. PRODISC-C IS A SPINAL IMPLANT INTENDED AS A REPLACEMENT FOR DISEASED/ DEGENERATED INTERVERTEBRAL DISCS OF THE CERVICAL SPINE. THE PRODISC-C TOTAL DISC REPLACEMENT PROCEDURE INVOLVES THE REMOVAL OF A DISEASED/ DEGENERATED DISC, AND SUBSEQUENT RESTORATION OF INTERVERTEBRAL DISC HEIGHT AND POTENTIAL FOR MOTION VIA PLACEMENT OF THE IMPLANT. BASED ON THE REVIEW OF THE RETURNED DEVICE AND THE INFORMATION PROVIDED, THE DESIGN IS CONSIDERED ADEQUATE FOR THE INTENDED USE OF THE DEVICE. (B)(6). (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.

    Additional Manufacturer Narrative · 1

    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

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH AN UNKNOWN PRODISC-C AT LEVELS C5-C6 ON AN UNKNOWN DATE IN 2013. THE PATIENT REPORTED NECK PAIN AND HEADACHES RADIATING PAIN INTO THE SHOULDERS BILATERALLY. THE PATIENT RETURNED TO THE OPERATING ROOM ON (B)(6) 2015 AND THE SURGEON REMOVED THE PRODISC-C IMPLANT. THE PATIENT WAS REVISED TO A 9MM ANTERIOR CERVICAL INTERBODY PEEK SPACER WITH A 14 MM SKYLINE PLATE AND FOUR (4) 4.0 X 14MM SCREWS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY AND NO HARM TO THE PATIENT. THIS REPORT IS FOR ONE UNKNOWN PRODISC-C IMPLANT. THIS REPORT IS 1 OF 1 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8731 PRODISC-C IMPLANT LARGE DEEP 5MM-STERILE PROSTHESIS INTERVERTEBRAL DISC MJO SYNTHES BRANDYWINE 7378548

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention