BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAGEN SUTURABLE DURAL REGENERATION TEMPLATE 2

    MDR report key: 6051666 · Received October 24, 2016

    Report

    Report Number
    3003418325-2016-00025
    Event Type
    Injury
    Date Received
    October 24, 2016
    Date of Event
    August 28, 2014
    Report Date
    September 29, 2016
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    GXQ
    PMA / PMN Number
    K120600
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 27 OCT 2016. -EVALUATION OF DEVICE FROM RETAINED SAMPLE OF FG LOTS. -REVIEW OF DEVICE HISTORY RECORDS. -REVIEW OF COMPLAINT HISTORY. ONE (1) PACKAGE OF SUTURABLE DURAGEN CATALOG DURS2291 CORRESPONDING TO FG LOT 1133978 AND ONE (1) PACKAGE OF DURAGEN XS CATALOG DXM1022 CORRESPONDING TO FG LOT 1132852 WERE REPORTED AS THE COMPLAINT UNITS. THE UNITS WERE NOT RETURNED FOR EVALUATION SINCE THE UNITS WERE IMPLANTED IN THE PATIENT. ONE (1) RETAIN SAMPLE OF FG LOT 1133978 AND ONE (1) RETAIN SAMPLE OF FG LOT 1132852 WERE VISUALLY EVALUATED FOR PRODUCT AND PACKAGING APPEARANCE TO CONFIRM NO DETERIORATION. NO SIGNS OF DETERIORATION WERE FOUND DURING THE RETAIN SAMPLES VISUAL EVALUATIONS. FINISHED GOODS (FG) LOT 1133978 ORIGINATES FROM (B)(4) IN-PROCESS MATERIAL- SUTURABLE DURAGEN X-LINK LOT 105000280710 AND FG LOT 1132852 ORIGINATES FROM (B)(4) IN-PROCESS MATERIAL- DURAGEN XS LOT 105000264128. BOTH (B)(4) LOTS WERE THEN TRANSFERRED TO (B)(4) FACILITY FOR FURTHER PROCESSING. THE MASTER NC/EVENT LOG WAS REVIEWED AS PART OF THE DHR REVIEWS. THERE WERE NO EVENTS/NCS FOUND FOR SUTURABLE DURAGEN X-LINK LOT 105000280710 NOR FOR DURAGEN XS LOT 105000264128. THERE WERE NO EVENTS/NCS FOUND RELATED TO SUTURABLE DURAGEN X-LINK NOR FOR DURAGEN XS CAUSING ADVERSE REACTION/CONDITION IN THE PATIENT. NO ANOMALIES WERE OBSERVED DURING THE MANUFACTURING AND PACKAGING PROCESS. ACCORDING TO THE DHR REVIEWS CONDUCTED FOR CMC-105 (B)(4) LOTS 105000280710, 105000264128, FG LOTS 1133978 AND 1132852; THERE IS NO INDICATION THAT THE PRODUCTION PROCESS OF THESE LOTS CONTRIBUTED TO THE COMPLAINTS EVENTS. NO ANOMALIES WERE REPORTED DURING THE MANUFACTURING AND PACKAGING PROCESSES OF THESE LOTS THAT COULD BE RELATED TO THE REPORTED CONDITION. NO SIMILAR COMPLAINTS RELATED TO ¿UNUSUAL DISEASE SYMPTOMS: PROGRESSIVE SUPRANUCLEAR PALSY¿ HAVE BEEN REPORTED FOR THESE FG LOTS 1133978 NOR FOR 1132852. UPON REVIEW OF INTEGRA¿S COMPLAINT SYSTEM FROM JULY 2013 TO OCTOBER 2016 TOTAL OF TWO (2) COMPLAINTS (ONLY THE TWO BEING INVESTIGATED) RELATED TO ¿UNUSUAL DISEASE SYMPTOMS: PROGRESSIVE SUPRANUCLEAR PALSY¿ FOR DURAGEN PRODUCT FAMILY HAVE BEEN REPORTED CONCLUSION: BASED ON INTEGRA¿S MEDICAL AFFAIRS INSIGHT: ¿PROGRESSIVE SUPRANUCLEAR PALSY (PSP) IS A RARE, PROGRESSIVE NEUROLOGICAL DISORDER THAT HAS NO KNOWN CAUSE. THE HALLMARK OF THE PATHOPHYSIOLOGY IS ABNORMAL DEPOSITION OF TAU, MUCH LIKE ALZHEIMER¿S DISEASE. THERE IS NO CONCLUSIVE EVIDENCE THAT PSP IS TRANSMISSIBLE THROUGH PRIONS OR THROUGH TRANSPLANTATION OF TISSUE FROM SPECIES TO SPECIES. THE CLINICIAN WAS NOT SUGGESTING A CAUSAL ROLE OF DURAGEN IN THIS PATIENT¿S CASE OF PSP, BUT WAS SIMPLY BEING CAUTIOUS AND ASKING IF INTEGRA HAD IDENTIFIED SIMILAR CASES IN ITS POST-MARKET SURVEILLANCE PROGRAM. THERE HAVE BEEN NO COMPLAINTS AT ALL FILED FOR EITHER LOT OF DURAGEN IN QUESTION. A CAUSAL RELATIONSHIP BETWEEN DURAGEN AND PSP IN THIS CASE IS EXTREMELY UNLIKELY¿.

    Description of Event or Problem · 1

    THIS IS THE FIRST OF TWO REPORTS (SAME PATIENT, SAME DEVICE, DIFFERENT PRODUCT ID, DIFFERENT LOT#). THIS REPORT IS IN REGARDS TO THE FIRST DURAGEN SUTURABLE DEVICE. LINKED TO MFG REPORT: 3003418325-2016-00026. ON (B)(6) 2014, A (B)(6) FEMALE PATIENT WAS UNDERGOING A POSTERIOR SPINAL FUSION OF T-11--SACRUM AND WAS IMPLANTED WITH TWO (2) SUTURABLE DURAGEN IMPLANTS. KYPHON BONE CEMENT WAS ALSO USED DURING THIS SURGERY. HER UNDERLYING MEDICAL CONDITION WAS SCOLIOSIS, PARKINSON'S PLUS VERSUS PROGRESSIVE SUPRANUCLEAR PALSY (THE DOCTOR WAS NOT SURE IF THIS CONDITION WAS AGGRAVATED BY THE PROCEDURE OR NEWLY ACQUIRED). THE PATIENT'S PRIOR MEDICAL HISTORY WAS UNREMARKABLE AND INCLUDED NO PREVIOUS SPINAL SURGERIES, MILD OSTEOARTHRITIS AND LUMBAR SCOLIOSIS. IN APRIL 2015 THE PATIENT PRESENTED WITH UNUSUAL DISEASE SYMPTOMS. SHE DEVELOPED A RARE PROGRESSIVE NEUROLOGICAL CONDITION CALLED PARKINSON'S PLUS, WHICH DOES NOT HAVE A KNOWN CAUSE, BUT THERE ARE SOME THEORIES THAT PRIONS COULD BE INVOLVED. SHE WAS NOT HOSPITALIZED FOR THE CONDITION SINCE FURTHER SURGERY WAS CONTRAINDICATED. SHE UNDERWENT PHYSICAL THERAPY AND A BONE STIMULATOR WAS PROVIDED; BOTH TREATMENTS WERE ALTERNATIVES TO SURGERY TO ALLEVIATE HER RECURRENT BACK PAIN, NOTHING WAS PROVIDED FOR HER NEUROLOGICAL SYMPTOMS. NO BLOOD CULTURES WERE TAKEN, AND NO IMAGING OR OPERATIVE REPORTS WERE NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701383 DURAGEN SUTURABLE DURAL REGENERATION TEMPLATE 2 N/A GXQ INTEGRA LIFESCIENCES CORPORATION 1133978

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other DXM1022 DURAGEN XS| KYPHON BONE CEMENT