BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS, RIB REPLACEMENT

    MDR report key: 4591618 · Received March 11, 2015

    Report

    Report Number
    2520274-2015-11598
    Event Type
    Injury
    Date Received
    March 11, 2015
    Report Date
    February 15, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    MDI
    PMA / PMN Number
    PH030009
    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. THIS REPORT IS FOR UNKNOWN VEPTR IMPLANT, UNKNOWN QUANTITY, UNKNOWN ITEM NUMBER, UNKNOWN LOT NUMBER. (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT AND 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

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE; (MAY 31, 2005) THE TREATMENT OF SPINE AND CHEST WALL DEFORMITIES WITH FUSED RIBS BY EXPANSION THORASOCTOMY AND INSERTION OF VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB. EMANS: ISSUE: VOLUME 30(17S) SUPPLEMENT, 1 SEPTEMBER 2005, PP S58-S68. THIS ARTICLE REPORTS COMPLICATIONS THAT WERE REPORTED IN STUDIES AND PROSPECTIVE CLINICAL TRIAL OF VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB (VEPTR) IN PATIENTS WITH COMBINED SPINE AND CHEST WALL DEFORMITY WITH SCOLIOSIS AND FUSED RIBS. ALSO, REPORT THE EFFICACY AND SAFETY OF EXPANSION THORACOSTOMY AND VEPTR SURGERY IN THE TREATMENT OF THORACIC INSUFFICIENCY SYNDROME (TIS) ASSOCIATED WITH FUSED RIBS. THE RESULTS REPORTED CONCERNING THIRTY-ONE PATIENTS WITH FUSED RIBS AND TIS WERE TREATED, 4 OF WHOM HAD UNDERGONE PRIOR SPINAL ARTHRODESIS AT OTHER INSTITUTIONS WITH CONTINUED PROGRESSION OF DEFORMITY. IN 30 PATIENTS, THE SPINAL DEFORMITY WAS CONTROLLED AND GROWTH CONTINUED IN THE THORACIC SPINE DURING TREATMENT AT RATES SIMILAR TO NORMALS. INCREASED VOLUME OF THE CONSTRICTED HEMITHORAX AND TOTAL LUNG VOLUMES OBTAINED DURING EXPANSION THORACOSTOMY WERE MAINTAINED AT FOLLOW-UP. TECHNIQUE RELATED COMPLICATIONS INCLUDED: PATIENT 9-(ID (B)(6)) WAS (B)(6) AT THE TIME OF THE EVENT. PATIENT¿S PRIMARY DIAGNOSIS WAS DEFORMITY DIAGNOSIS FUSED RIBS AND CONGENITAL SCOLIOSIS. VEPTR CONSTRUCT AT 1 RIB-TO-RIB AND 1 RIB-TO-SPINE WITH NO DEVICE MIGRATION. PATIENT SHOWED RE-FUSION ON CT BETWEEN RIBS IN THE AREA OF PREVIOUSLY RIB OSTEOTOMY AND EXPANSION THORACOSTOMY. PATIENT UNDERWENT REPEAT SEPARATION OF RIBS, RESECTION OF BRIDGING BONE AND THORASOCTOMY AT THE TIME OF DEVICE EXCHANGE/ CONVERSION. IMPROVED SPINAL CURVE CORRECTION WAS NOTED IN BOTH AFTER REPEAT THORACOSTOMY. PATIENT AT THE TIME OF DEVICE EXCHANGE PRESENTED WITH DENSE SOFT TISSUE, SCARRING WAS NOTED ON THE CHEST WALL BENEATH THE DEVICES. PATIENT HAD SEVERE PREOPERATIVE DEFORMITY DUE TO MULTIPLE FUSED RIBS AND CHEST WALL DEFICIENCY, FRACTURE OF THE UPPER RIB ATTACHMENTS OCCURRED AT THE TIME OF THE INITIAL PROCEDURE. CORRECTION WAS REDUCED AND THE RIBS ALLOWED HEALING. ATTEMPTS AT REVISION AFTER THE RIBS HAD HEALED FAILED TO ACHIEVE ADEQUATE FIXATION AT THE UPPER POINTS OF ATTACHMENT, AND THIS PATIENT IS PRESENTLY MANAGED WITH BOTH THE ORIGINAL VEPTR DEVICES AND EXTENSIBLE SPINAL RODS. THE PROCEDURE RELATED COMPLICATIONS INCLUDE RIB FRACTURE /AVULSIONS REQUIRING REVISION AND ADDITIONAL OF GROWING RODS. THIS REPORT IS FOR 8 OF 18 FOR (B)(4). THIS PART DATA FOR UNKNOWN VEPTR, UNKNOWN QUANTITY, PART AND LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169399 PROSTHESIS, RIB REPLACEMENT MDI SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Required Intervention