BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SCREWS

    MDR report key: 9431882 · Received December 6, 2019

    Report

    Report Number
    1526439-2019-52618
    Event Type
    Injury
    Date Received
    December 6, 2019
    Report Date
    November 14, 2019
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    MNH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). SURGICAL INTERVENTION IN THE FORM OF REVISION SURGERY.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN SCREWS/UNKNOWN LOT NUMBER. WITHOUT THE SPECIFIC PART NUMBER, THE UDI NUMBER AND 510K 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. 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. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: SALEHANI, A. ET AL. (2016) FLOATING THORACIC SPINE AFTER DOUBLE, NONCONTIGUOUS THREE-COLUMN SPINAL FRACTURES.WORLD NEUROSURGERY 91:670.E7-670.E11. 2016. THIS CASE PRESENTS A (B)(6) MAN WHO HAD DOUBLE-LEVEL SPINAL INJURY ISOLATED TO THE THORACIC SPINE, WITH AN INTERMEDIATE FLOATING SPINAL SEGMENT AFTER A 30-FOOT FALL. HE WAS FOUND TO HAVE AN AMERICAN SPINAL INJURY ASSOCIATION A SPINAL CORD INJURY WITH A T6 SENSORY LEVEL. FINDINGS OF A COMPUTED TOMOGRAPHY SCAN REVEALED A FRACTURE DISLOCATION AT T5-6, WITH A SECOND FRACTURE DISLOCATION AT T9-10. BOTH FRACTURES INVOLVED THE ANTERIOR, MIDDLE, AND POSTERIOR COLUMNS WITH AN INTERVENING SEGMENT OF ¿FLOATING¿ THORACIC SPINE. THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR OPEN REDUCTION AND POSTERIOR INSTRUMENTED FIXATION FROM T2 (3 LEVELS ABOVE THE ROSTRAL FRACTURE LEVEL) TO T12 (2 LEVELS BELOW THE CAUDAL FRACTURE LEVEL). DEPUY SYNTHES EXPEDIUM (RAYNAM, MASSACHUSETTS, USA) PEDICLE SCREWS MEASURING 4.35 MM X 30 MM (T4-6 BILATERALLY); 4.35 X 35 MM (T7-9 BILATERALLY); 4.35 X 40 MM (BILATERALLY T10); AND 4.35 X 40 AND 5.0 X 40 MM WERE USED ON THE LEFT AND RIGHT, RESPECTIVELY, AT T11 AND 5.0 X 40 MM BILATERALLY AT T12. TWO 375-MM TITANIUM RODS OF 5.5 MM IN DIAMETER WERE USED AND FASHIONED WITH SLIGHT KYPHOSIS. FINALLY, 90 ML OF CORTICAL CANCELLOUS BONE ALLOGRAFT WAS MIXED WITH LOCAL LAMINAR AUTOGRAFT FOR POSTEROLATERAL ARTHRODESIS. SIX MONTHS LATER, THE PATIENT REPORTED A NEW GRATING SENSATION AND THE FORMATION OF KNOT IN HIS BACK AFTER FLEXION WHILE STRETCHING TO TOUCH HIS TOES. IMAGING REVEALED HARDWARE FAILURE WITH PULLOUT OF THE PEDICLE SCREWS AT T11 AND T12, COLLAPSE OF THE T10 VERTEBRAL BODY, AND WORSENING KYPHOSIS. THE PATIENT UNDERWENT A LATERAL T10 CORPECTOMY WITH A T9-T11 EXPANDABLE POLYETHERETHERKETONE CAGE AND INTERBODY ARTHRODESIS WITH USE OF RIB AUTOGRAFT. THE POSTERIOR INSTRUMENTATION WAS EXTENDED AND INCLUDED A TRANSPEDICULAR TRANSDISCAL SCREW FROM T12 TO T11 AND SEGMENTAL PEDICLE SCREW FIXATION CAUDALLY TO L3 AND A QUAD-ROD CONSTRUCT WITH DUAL TITANIUM AND DUAL COBALT CHROME RODS WERE USED FOR ADDED STABILITY. IN CONCLUSION, IN THE CASE OF SEVERE, NONCONTIGUOUS DOUBLE CHANCE FRACTURES OF THE SPINE, A MORE EXTENSIVE ANTERIOR POSTERIOR APPROACH TO REDUCE THE RISK OF HARDWARE FAILURE AND WORSENING SPINAL DEFORMITY IS RECOMMENDED. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: A (B)(6) MAN WHO REPORTED A NEW GRATING SENSATION AND THE FORMATION OF KNOT IN HIS BACK AFTER FLEXION WHILE STRETCHING TO TOUCH HIS TOES. IMAGING REVEALED HARDWARE FAILURE WITH PULLOUT OF THE PEDICLE SCREWS AT T11 AND T12, COLLAPSE OF THE T10 VERTEBRAL BODY, AND WORSENING KYPHOSIS. DEPUY SPINE PRODUCT: THIS REPORT ARE FOR EXPEDIUM (RAYNAM, MASSACHUSETTS, USA) PEDICLE SCREWS. THIS REPORT IS FOR ONE (1) UNKNOWN SCREWS. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1218235 UNKNOWN SCREWS VSP SPINE SYSTEM MNH MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention