BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS, INTERVERTEBRAL DISC

    MDR report key: 4769611 · Received May 13, 2015

    Report

    Report Number
    2530088-2015-10155
    Event Type
    Injury
    Date Received
    May 13, 2015
    Report Date
    April 28, 2015
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    PP050010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SIEPE, C. (2005). CLINICAL RESULTS OF TOTAL LUMBAR DISC REPLACEMENT WITH PRODISC II. SPINE, VOLUME 31, PP 1923 ¿ 1932. THIS REPORT IS FOR AN UNKNOWN PRODISC-II/UNKNOWN QUANTITIES POLYETHYLENE INLAY/UNKNOWN LOT. UDI: UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. (B)(6). SYMPATHECTOMY RELATED DYSESTHESIA (1 PATIENT), POSTOPERATIVE EXTRAFORAMINAL DISC PROTRUSION FOLLOWING TDR (1 PATIENT- SPONTANEOUS IMPROVEMENT UPON CONSERVATIVE THERAPY), PRIMARY SUBOPTIMAL IMPLANTATION (1 PATIENT- SECONDARY DISLOCATION + FUSION), SEGMENTAL HYPERLORDOSIS PERSISTING PROBLEMS (1 PATIENT, POSTERIOR DYNAMIC FIXATION (DYNESIS)), PERSISTING FACET JOINT PROBLEMS (2 PATIENTS ¿ SECONDARY FUSION), AND REOPERATIONS- ADJACENT SEGMENT DISC HERNIATION (2 PATIENTS- MICROSURGICAL DISCECTOMY); SECONDARY SPINAL CANAL STENOSIS (1 PATIENT ¿ MICROSURGICAL DECOMPRESSION). THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. 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

    LITERATURE ARTICLE RECEIVED. THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: SIEPE, C. (2005). CLINICAL RESULTS OF TOTAL LUMBAR DISC REPLACEMENT WITH PRODISC II. SPINE, VOLUME 31, PP 1923 ¿ 1932. (GERMANY). THIS ARTICLE IS FOR A PROSPECTIVE STUDY ANALYZING MIDTERM CLINICAL RESULTS OF TOTAL LUMBAR DISC REPLACEMENT (PRODISC II) FOR DIFFERENT INDICATIONS IN ORDER TO ASSESS FUNCTIONAL OUTCOME AFTER TOTAL LUMBAR DISC REPLACEMENT (TDR) TREATED FOR VARYING INDICATIONS. THE STUDY DESIGN WAS A PROSPECTIVE, NONRANDOMIZED STUDY FROM JULY 2000 TO JULY 2005 OF 92 PATIENTS. PATIENTS WERE DIVIDED INTO FOUR GROUPS ACCORDING TO THEIR PREOPERATIVE DIAGNOSIS- GROUP 1: DEGENERATIVE DISC DISEASE (DDD), GROUP 2: DDD PLUS DISC HEMIATION, GROUP 3: POST ¿ DISCECTOMY, AND GROUP 4: DDD PLUS MODIC. PATIENTS WERE EXAMINED AND PATIENT DATA WAS COLLECTED BEFORE SURGERY, 3-MONTHS POST-OPERATIVELY, 6-MONTHS POST-OPERATIVELY, 12- MONTHS POST-OPERATIVELY, AND ANNUALLY FROM THEN ON. ALL PATIENTS WERE NONRESPONDERS TO A PREOPERATIVE INTENSIVE CONSERVATIVE INPATIENT AND OUTPATIENT TREATMENT PROGRAM. LOW BACK PAIN (LBP) WAS THE PREDOMINANT AND LEADING COMPLAINT IN ALL PATIENTS. 18 OF THE PATIENTS (19.6%) EXPERIENCED COMPLICATIONS. 18 PATIENTS (19.6%) EXPERIENCED COMPLICATIONS. THE FOLLOWING COMPLICATIONS WERE INTRAOPERATIVE: RETROGRADE EJACULATION (2 PATIENTS- 1 PERSISTING AND 1 TEMPORARY), AND SYMPATHECTOMY RELATED DYSESTHESIA (1 PATIENT). THE FOLLOWING COMPLICATIONS WERE POSTOPERATIVE: DEEP VEIN THROMBOSIS + ARTERIAL PULMONARY EMBOLISM + LYSIS (1 PATIENT- PATIENT WITH KNOWN COAGULOPATHY), AND SUPERFICIAL WOUND HEALING IMPAIRED (1 PATIENT). THE FOLLOWING COMPLICATIONS WERE POSTOPERATIVE: EXTRAFORAMINAL DISC PROTRUSION FOLLOWING TDR (1 PATIENT- SPONTANEOUS IMPROVEMENT UPON CONSERVATIVE THERAPY), NEUROPATHY L5 (1 PATIENT), HETEROTOPIC OSSIFICATION (1 PATIENT- TYPE III MCAFEE CLASSIFICATION), INTRAOPERATIVE/POSTOPERATIVE COMPLICATIONS TOTAL (8 PATIENTS), REOPERATIONS (8 PATIENTS), PRIMARY SUBOPTIMAL IMPLANTATION (1 PATIENT- SECONDARY DISLOCATION + FUSION), INLAY DISLOCATION (1 PATIENT ¿ IMPLANT REPLACED), IMPLANT SUBSIDENCE (2 PATIENTS ¿ SECONDARY FUSION OPERATION), SEGMENTAL HYPERLORDOSIS PERSISTING PROBLEMS (1 PATIENT, POSTERIOR DYNAMIC FIXATION (DYNESIS)), PERSISTING FACET JOINT PROBLEMS (2 PATIENTS ¿ SECONDARY FUSION), SECONDARY SPINAL CANAL STENOSIS (1 PATIENT ¿ MICROSURGICAL DECOMPRESSION), AND REOPERATIONS- ADJACENT SEGMENT DISC HERNIATION (2 PATIENTS- MICROSURGICAL DISCECTOMY). THIS REPORT IS FOR THE FOLLOWING EVENTS: SYMPATHECTOMY RELATED DYSESTHESIA (1 PATIENT), POSTOPERATIVE EXTRAFORAMINAL DISC PROTRUSION FOLLOWING TDR (1 PATIENT- SPONTANEOUS IMPROVEMENT UPON CONSERVATIVE THERAPY), NEUROPATHY L5 (1 PATIENT), HETEROTOPIC OSSIFICATION (1 PATIENT- TYPE III MCAFEE CLASSIFICATION), REOPERATIONS (8 PATIENTS), PRIMARY SUBOPTIMAL IMPLANTATION (1 PATIENT- SECONDARY DISLOCATION + FUSION), SEGMENTAL HYPERLORDOSIS PERSISTING PROBLEMS (1 PATIENT, POSTERIOR DYNAMIC FIXATION (DYNESIS)), PERSISTING FACET JOINT PROBLEMS (2 PATIENTS ¿ SECONDARY FUSION), SECONDARY SPINAL CANAL STENOSIS (1 PATIENT ¿ MICROSURGICAL DECOMPRESSION), AND REOPERATIONS- ADJACENT SEGMENT DISC HERNIATION (2 PATIENTS- MICROSURGICAL DISCECTOMY). THE EVENTS THAT WERE NOT INCLUDED WERE DETERMINED TO BE UNRELATED TO THE DEVICE ITSELF AND ARE CONSIDERED AS POTENTIAL OPERATIVE OR POSTOPERATIVE COMPLICATIONS. THIS IS REPORT 3 OF 6 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN PRODISC-II DEVICE, UNKNOWN PART#/LOT#.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314517 PROSTHESIS, INTERVERTEBRAL DISC MJO SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention