BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CAGE/SPACER

    MDR report key: 12269220 · Received August 3, 2021

    Report

    Report Number
    1526439-2021-01601
    Event Type
    Injury
    Date Received
    August 3, 2021
    Report Date
    July 6, 2021
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    OVD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS FOR AN UNKNOWN CAGE/SPACER/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/ INVESTIGATION. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. THE PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: YASMEH, S. ET AL. (2021), CLINICAL AND RADIOGRAPHIC OUTCOMES OF LATERAL INTERBODY FUSION FOR ADJACENT SEGMENT DEGENERATION, INTERNATIONAL JOURNAL OF SPINE SURGERY, VOL. 15, NO. 1, PAGES 74-81 (USA). THE PURPOSE OF THIS STUDY WAS TO REPORT ON CLINICAL AND RADIOGRAPHIC OUTCOMES OF LATERAL LUMBAR INTERBODY FUSION WITH SUPPLEMENTAL LATERAL OR POSTERIOR INSTRUMENTATION FOR ADJACENT SEGMENT DEGENERATION ABOVE A PREVIOUS LUMBAR FUSION. BETWEEN OCTOBER 2014 AND DECEMBER 2017, A TOTAL OF 36 PATIENTS WITH PREVIOUS LUMBAR POSTERIOR SPINAL FUSION WHO PRESENTED WITH ADJACENT SEGMENT DEGENERATION AND STENOSIS REFRACTORY TO NONOPERATIVE TREATMENT UNDERWENT LATERAL LUMBAR INTERBODY FUSION USING A TITAN TITANIUM CAGE (TITAN SPINE, INC, MEQUON, WI), COUGAR POLYETHER ETHER KETONE (PEEK)/CARBON FIBER CAGE (DEPUY SYNTHES SPINE, INC, RAYNHAM, MA), CLYDESDALE PEEK CAGE (MEDTRONIC, INC, MEMPHIS, TN), OR PIVOX PEEK CAGE (MEDTRONIC, INC). BIOLOGICS IN THE INTERBODY CAGE CONSISTED OF DEMINERALIZED BONE MATRIX (DBM) ALLOGRAFT BONE (DBX, DEPUY SYNTHES, ZUCHWIL, SWITZERLAND) ALONE IN 22 PATIENTS WITH TITAN CAGES, DBM AND LOCAL AUTOGENOUS RIB BONE HARVESTED DURING AN L1-2 APPROACH IN 4 PATIENTS WITH TITAN CAGES, DBM AND BONE MORPHOGENETIC PROTEIN (BMP) (INFUSE RHBMP2, MEDTRONIC, INC, MINNEAPOLIS, MN) IN 8 PATIENTS WITH DEPUY SYNTHES OR MEDTRONIC PEEK CAGES, AND WITH A COMBINATION OF DBM, BMP, AND LOCAL AUTOGENOUS BONE IN 2 PATIENTS WITH DEPUY SYNTHES OR MEDTRONIC PEEK CAGES. THERE WERE 19 FEMALE AND 17 MALE PATIENTS WITH A MEAN AGE OF 60.3 (9.7) YEARS. PATIENTS WERE FOLLOWED FOR A MEAN OF 19.6 (13) MONTHS. THE FOLLOWING COMPLICATIONS WERE REPORTED: A MALE PATIENT HAD A PROXIMAL JUNCTIONAL FAILURE THROUGH THE VERTEBRAL BODY IN THE FORM OF AN L2 VERTEBRAL BODY FRACTURE 6 WEEKS AFTER SURGERY. HE WAS FOUND TO HAVE OSTEOPOROSIS AND WAS STARTED ON PHARMACOLOGIC TREATMENT FOR BONE HEALTH OPTIMIZATION AND SUBSEQUENTLY UNDERWENT PROXIMAL EXTENSION OF HIS POSTERIOR FUSION CONSTRUCT TO T10. A FEMALE PATIENT DEVELOPED AN INCISIONAL HERNIA AT THE SITE OF THE LATERAL SURGERY WITH DISCOMFORT IN THIS AREA. SHE UNDERWENT A LAPAROSCOPIC HERNIA REPAIR WITH RESOLUTION OF HER SYMPTOMS. A FEMALE PATIENT HAD A CLINICAL PICTURE CONSISTENT WITH A DURAL TEAR IN THE POSTOPERATIVE PERIOD AND RETURNED TO THE OPERATING ROOM FOR EXPLORATION. SHE WAS FOUND TO HAVE A LARGE DURAL TEAR AT THE SITE OF A REVISION LAMINECTOMY, ALTHOUGH NO DURAL DEFECT WAS PRESENT DURING THE PRIOR SURGERY, THOUGH THE DURA WAS NOTED TO BE UNDER TENSION AS A RESULT OF DISK HEIGHT RESTORATION AND INCREASED LORDOSIS AS A RESULT OF THE INTERBODY CAGE PLACEMENT. THE DURA WAS UNABLE TO BE REPAIRED WITHOUT TENSION, AND SO A FASCIAL GRAFT WAS USED SUCCESSFULLY WITHOUT FURTHER INCIDENT. A MALE PATIENT CONTINUED TO HAVE PERSISTENCE OF LOWER EXTREMITY PAIN AND WEAKNESS AFTER A STANDALONE LATERAL INTERBODY FUSION WITH LATERAL PLATING. REPEAT MAGNETIC RESONANCE IMAGING DEMONSTRATED THAT AN INDIRECT DECOMPRESSION BY THE INTERBODY CAGE WAS INSUFFICIENT AND THERE WAS PERSISTENT MODERATE TO SEVERE STENOSIS AT THE LEVEL OF HIS LATERAL SURGERY THAT WAS FELT TO BE CONTRIBUTING TO HIS PERSISTENT SYMPTOMS. HE UNDERWENT A LAMINECTOMY FOR DIRECT DECOMPRESSION WITH IMPROVEMENT OF HIS LOWER EXTREMITY PAIN BUT NO IMPROVEMENT IN THE WEAKNESS THAT PROMPTED THE ORIGINAL SURGERY. 2 PATIENTS DEVELOPED SYMPTOMATIC PROXIMAL ADJACENT SEGMENT DISEASE FOR WHICH THEY UNDERWENT SURGICAL TREATMENT. 2 PATIENTS UNDERWENT PARTIAL INSTRUMENTATION REMOVAL FOR SYMPTOMATIC POSTERIOR INSTRUMENTATION AT THE PROXIMAL ASPECT OF THEIR FUSION CONSTRUCT WITH RESOLUTION OF THEIR DISCOMFORT. 6 PATIENTS HAD PERSISTENT PAIN, THOUGH IN ALL 6 CASES, THE PAIN WAS LESS POSTOPERATIVELY THAN PREOPERATIVELY. TWO OF THE 6 PATIENTS WITH RESIDUAL SYMPTOMS HAD BACK AND RADICULAR PAIN, 3 PATIENTS HAD BACK PAIN ONLY, AND 1 PATIENT HAD RADICULAR PAIN ONLY. THIS REPORT IS FOR AN UNKNOWN SYNTHES COUGAR PEEK CAGE. THIS REPORT IS FOR (1) UNKNOWN CAGE/SPACER. THIS REPORT IS 2 OF 5 FOR (B)(4). RELATED PRODUCT COMPLAINT: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1164720 UNKNOWN CAGE/SPACER INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,LUMBAR OVD MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention