BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS, RIB REPLACEMENT

    MDR report key: 8746448 · Received June 28, 2019

    Report

    Report Number
    2939274-2019-58925
    Event Type
    Injury
    Date Received
    June 28, 2019
    Report Date
    June 4, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    MDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN - VEPTR IMPLANTS/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. (B)(4). THE REPORTED EVENT REQUIRED MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE AND SURGICAL INTERVENTION. THE ARTICLE GROUPS COMPLICATIONS INTO GROUPS, THIS REPRESENTS IMPLANT RELATED. THE ARTICLE DOES NOT DIRECTLY STATE BUT IT PROVIDED THE FOLLOWING AS EXAMPLES: ROD BREAKAGE (BROKEN). CONSERVATIVELY THIS WILL BE REPORTED FOR THESE COMPLICATIONS. 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. INVESTIGATION SUMMARY 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. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: BACHABI M. ET AL (2018), IDIOPATHIC EARLY-ONSET SCOLIOSIS: GROWING RODS VERSUS VERTICALLY EXPANDABLE PROSTHETIC TITANIUM RIBS AT 5-YEAR FOLLOW-UP, J PEDIATR ORTHOP, VOLUME 00, NUMBER 00, PAGES 1-7, (USA). THE PURPOSE OF THIS STUDY WAS TO EVALUATE LONG-TERM CLINICAL AND RADIOGRAPHIC RESULTS OF TRADITIONAL GROWING RODS (TGR) VERSUS VERTICALLY EXPANDABLE TITANIUM RIBS (VEPTR) TREATMENT FOR IDIOPATHIC EOS. FROM 1993 THROUGH 2009, 50 PATIENTS TREATED WITH A COMPETITOR¿S TRADITIONAL GROWING RODS (TGR) AND 22 PATIENTS TREATED WITH AN UNKNOWN SYNTHES VERTICALLY EXPANDABLE TITANIUM RIBS (VEPTR) FOR AN IDIOPATHIC EARLY-ONSET SCOLIOSIS (EOS) WITH A MINIMUM OF 5-YEAR FOLLOW-UP AFTER THE INITIATION OF ¿GROWTH-FRIENDLY SURGERY¿, AND WITH 4 OR MORE LENGTHENING WERE INCLUDED IN THE STUDY. 11 PATIENTS RECEIVED UNILATERAL VEPTR CONSTRUCTS AND 11 PATIENTS RECEIVED BILATERAL VEPTR CONSTRUCTS. THE MEAN AGE AT THE TIME OF THE INITIAL PROCEDURE FOR THE VEPTR PATIENTS WAS 4.3 YEARS WITH A MEAN FOLLOW-UP DURATION OF 7.7 YEARS. COMPLICATIONS WERE EVALUATED AND WERE CATEGORIZED AS MEDICAL/SURGICAL (IE, POSTOPERATIVE CARDIOPULMONARY OR GASTROINTESTINAL COMPLICATIONS, DURAL TEARS, MYELOPATHY, PARESTHESIA, POSTOPERATIVE WEAKNESS), OR AS RELATED TO THE WOUND (IE, SUPERFICIAL INFECTION, DEEP INFECTION), THE IMPLANT (IE, ROD BREAKAGE, ANCHOR FAILURE, IMPLANT PROMINENCE), OR ALIGNMENT (IE, PROXIMAL JUNCTIONAL KYPHOSIS OF AT LEAST 10 DEGREES OR 10 DEGREES GREATER THAN PREOPERATIVE MEASUREMENT). COMPLICATIONS WERE REPORTED AS FOLLOWS: (UNILATERAL VEPTR)- 6 PATIENTS HAD IMPLANT-RELATED COMPLICATIONS. 4 PATIENTS HAD WOUND-RELATED COMPLICATIONS. (BILATERAL VEPTR)- 9 PATIENTS HAD IMPLANT-RELATED COMPLICATIONS. 5 PATIENTS HAD WOUND-RELATED COMPLICATIONS. 2 PATIENTS HAD MEDICAL OR SURGICAL RELATED COMPLICATIONS. UNKNOWN PATIENTS HAD MAJOR KYPHOSIS PROGRESSED TO A GREATER EXTENT (MEAN, 31 DEGREES). THIS REPORT IS FOR ONE (1) DEVICE- UNKNOWN SYNTHES VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB (VEPTR). THIS IMPACTED PRODUCT CAPTURES THE FOLLOWING REPORTED EVENT: IMPLANT-RELATED COMPLICATIONS. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536990 PROSTHESIS, RIB REPLACEMENT MDI WRIGHTS LANE SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention