BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 6309872 · Received February 8, 2017

    Report

    Report Number
    1030489-2017-00232
    Event Type
    Injury
    Date Received
    February 8, 2017
    Report Date
    January 9, 2017
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ALTHOUGH IT IS UNKNOWN WHICH OF THE DEVICES LEAD TO THE EVENT, WE ARE FILING THIS REPORT FOR NOTIFICATION PURPOSES. MULTIPLE DEVICES INVOLVED INT THE EVENT ARE AS FOLLOWS: PART #: 869-022, LOT #: UNK, QTY: 1, UPN #: (B)(4), 510K: K040962, IMPLANT DATE: (B)(6) 2009. PART #: 7541123, LOT #: UNK, QTY: 1 , UPN #: (B)(4), 510K: K031655, IMPLANT DATE: (B)(6) 2009. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON: (B)(6) 2009: PATIENT PRESENTED WITH FOLLOWING PRE-OP DIAGNOSES: KYPHOSIS ACQUIRED. OSTEOPOROSIS. HISTORY OF CRANIOPHARYNGIOMA. FOR WHICH, PATIENT UNDERWENT FOLLOWING PROCEDURES: POSTERIOR SPINAL FUSION WITH SEGMENTAL INSTRUMENTATION T2 THROUGH T10. IMAGE-GUIDED SURGERY. SMITH-PETERSEN OSTEOTOMIES, T6-7 AND T7-8. T5 VERTEBRAL COLUMN RESECTION. INSERTION OF STRUCTURAL INTERVERTEBRAL DEVICE. APPLICATION GARDNER-WELLS TONGS. PATIENT IS WITH A HISTORY OF A T5 FRACTURE AND A MARKED PROGRESSIVE SYMPTOMATIC KYPHOTIC DEFORMITY. PER OP NOTES, T5 DISK SPACE WAS IDENTIFIED. INITIALLY, A 13 X 30 MM HIGH MESH CAGE WAS SELECTED AND THIS HAD TO BE TRIMMED BACK ABOUT 8-9 MM. THIS WAS THEN FILLED WITH LOCAL BONE AND A BONE MORPHOGENIC PROTEIN (BMP) SPONGE. THIS WAS THEN SEATED INTO PLACE AT THAT T5 DEFECT LEVEL. THIS WAS DONE FROM THE RIGHT SIDE. THE LOCAL BONE PLUS 60 ML OF ALLOGRAFT BONE ALONG WITH THE REMAINING 5 SPONGES FROM THE LARGE BMP KIT WERE USED TO PERFORM THE POSTERIOR FUSION. AT T10, 6.5 X 45 MM SCREWS WERE PLACED BILATERALLY PATIENT TOLERATED THE PROCEDURE WELL WITHOUT ANY INTRAOPERATIVE COMPLICATIONS. ON (B)(6) 2009: PATIENT PRESENTED WITH FOLLOWING PRE-OP DIAGNOSES: KYPHOSIS ACQUIRED AND LOSS OF FIXATION. OSTEOPOROSIS. CRANIOPHARYNGIOMA. FOR WHICH, PATIENT UNDERWENT FOLLOWING PROCEDURES: KYPHOPLASTIES L 1 AND L2. SMITH-PETERSON OSTEOTOMY, T11-T12. POSTERIOR SPINAL FUSION WITH SEGMENTAL INSTRUMENTATION T9 THROUGH T12. INDICATION OF OPERATION: PATIENT HAD INITIAL EXCELLENT CORRECTION, BUT THEN DEMONSTRATED FALLING OF THE SCREWS AT HER DISTAL INSTRUMENTED LEVEL OF T10 WHICH ON CT SCAN AND INTRAOPERATIVELY APPEARED TO BE CONSISTENT WITH A CHANCE-TYPE FRACTURE ALONG WITH THE LOSS OF ALIGNMENT. BECAUSE OF THIS, THE RECOMMENDATION WAS MADE FOR REVISION OF THE INSTRUMENTATION WITH EXTENSION OF HER FUSION DOWN TO T12 ALONG WITH VERTEBRAL BODY AUGMENTATION AT THE 2 LEVELS DISTAL TO THIS. PER OP NOTES, THE SET PLUGS WERE REMOVED FROM THE DISTAL 3 INSTRUMENTED SEGMENTS. THE RODS WERE BENT UP AND OUT OF THE WAY. THE T10 SCREWS WERE REMOVED. THE FRACTURE SITE WAS INVESTIGATED AND FOUND TO BE CONSISTENT WITH A CHANCE FRACTURE AND WE MADE THE DECISION NOT TO TRY TO AUGMENT THIS VERTEBRAL BODY OR TO KYPHOPLASTY IT AS THERE WAS DISRUPTION OF THE PEDICLE TRACTS BILATERALLY. A TRANSFACIAL APPROACH WAS PERFORMED TO DO KYPHOPLASTIES AT L1 AND L2. ALLOGRAFT BONE ALONG WITH BMP WAS THEN USED TO PERFORM A POSTERIOR AND POSTEROLATERAL FUSION. PATIENT TOLERATED THE PROCEDURE WELL WITHOUT ANY INTRAOPERATIVE COMPLICATIONS. ON (B)(6) 2012: PATIENT PRESENTED WITH FOLLOWING PRE-OP DIAGNOSES: HARDWARE PROTRUSION. FOR WHICH, PATIENT UNDERWENT FOLLOWING PROCEDURE: SPINAL FUSION HARDWARE THORACIC LEVEL CROSSLINK REMOVAL. INDICATION FOR PROCEDURE: PATIENT COMPLAINED ABOUT LUMP AND ALSO HAD PAIN IN THORACIC AREA. X-RAY SCAN SHOWED THIS LUMP FROM THE PREVIOUSLY PLACED HARDWARE CROSSLINK. DECISION WAS MADE ON HARDWARE CROSSLINK REMOVAL. PER OP NOTES, HARDWARE CROSSLINK WAS SEEN AND SCREWS AND CONNECTION POINTS OF THE CROSSLINK WERE IDENTIFIED. THEN, SCREWS WERE REMOVED FROM THE LATERAL RODS. THEN, CROSSLINK WAS REMOVED. DURING THE PROCEDURE, CONFIRMATORY X-RAY WAS PERFORMED WHICH SHOWED CORRECT LOCATION AND CORRECT CROSSLINK REMOVAL. PATIENT TOLERATED THE PROCEDURE WELL WITHOUT ANY INTRAOPERATIVE COMPLICATIONS. ON (B)(6) 2010: PATIENT PRESENTED WITH FOLLOWING PRE-OP DIAGNOSES: PAINFUL THORACIC HARDWARE. FOR WHICH, PATIENT UNDERWENT FOLLOWING PROCEDURES: REMOVAL OF RIGHT T12 SUBLAMINAR HOOK AND ROD. INDICATION FOR PROCEDURE: PATIENT NOW HAS DEVELOPED PAIN ON THE RIGHT SIDE AT THE LOWER ASPECT OF THE HARDWARE. RADIOGRAPHICALLY, THIS AREA CORRESPONDS TO THE SUB LAMINAR HOOK AT T12. PER OP NOTES, THE PROTUBERANCE ON THE PATIENT'S BACK INDEED DID CORRESPOND WITH THE RIGHT T12 SUBLAMINAR HOOK. THE CAP WAS REMOVED FROM THIS HOOK. THE ROD WAS THEN INSPECTED. THERE WAS EVIDENCE OF BONY FUSION OVER THE DORSAL ASPECT OF THE ROD. THE CUT WAS MADE JUST CAUDAL TO THE T12 PEDICLE SCREW. THIS SEGMENT OF ROD WAS THEN REMOVED. THE SUB LAMINAR HOOK WAS THEN INSPECTED AND ALSO REMOVED. IT DID APPEAR THAT THE SUBLAMINAR HOOK WAS STILL IN ITS PROPER POSITION ON THE T12 LAMINA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94731 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other| R