BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPEEDTRIAD COMPRESSION IMPLANT KIT 18X15X8MM CENTERED

    MDR report key: 6727599 · Received July 20, 2017

    Report

    Report Number
    1649263-2017-10015
    Event Type
    Injury
    Date Received
    July 20, 2017
    Report Date
    June 22, 2017
    Manufacturer
    BIO MEDICAL ENTERPRISES INC
    Product Code
    JDR
    PMA / PMN Number
    K133844
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: EXPIRATION DATE: SEPTEMBER 1, 2020. UDI: (B)(4). DHR REVIEW WAS COMPLETED. NO RELEVANCE TO COMPLAINT CONDITION. DHR REVIEW: PART NUMBER: SE-181508TRC. BME LOT NUMBER: BMESE155223. LOT EXPIRATION DATE: 1 SEPT 2020. MANUFACTURING DATE OR RELEASE TO WAREHOUSE DATE: 19 OCT 2015. NO NCMRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO RELEVANCE TO COMPLAINT CONDITION. DHR REVIEW (PARENT LOT): PART NUMBER: SE-181508TRC. BME LOT NUMBER: BMESE155094A. MANUFACTURING DATE OR RELEASE TO WAREHOUSE DATE: 21 MAY 2015. NO NCMRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO RELEVANCE TO COMPLAINT CONDITION. DHR REVIEW (PARENT LOT): PART NUMBER: SE-181508TRC. BME LOT NUMBER: BMESE155058A. MANUFACTURING DATE OR RELEASE TO WAREHOUSE DATE: 12 MAY 2015. NO NCMRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO RELEVANCE TO COMPLAINT CONDITION. DHR REVIEW (PARENT LOT): PART NUMBER: SE-181508TRC. BME LOT NUMBER: BMESE155061A. MANUFACTURING DATE OR RELEASE TO WAREHOUSE DATE: 12 MAY 2015. NO NCMRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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.

    Additional Manufacturer Narrative · 1

    DATE OF BIRTH (B)(6); EXACT DATE IS UNKNOWN. PATIENT¿S WEIGHT IS UNKNOWN. DATE OF POSTOPERATIVE STAPLE BREAKAGE IS UNKNOWN. (B)(4). EXPLANT DATE: UNKNOWN. COMPLAINANT DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED AND IS CURRENTLY PENDING COMPLETION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    IT WAS REPORTED THAT THE PROXIMAL ASPECT OF LEG OF A (BME) BIOMEDICAL ENTERPRISE TRIAD STAPLE WAS BROKEN. THE PATIENT WAS SEEN IN THE OFFICE COMPLAINING OF PAIN AT THE IMPLANT SITE. THE ORIGINAL IMPLANT DATE WAS (B)(6) 2016. THE PATIENT STATUS WAS REPORTED AS FUSED. THE DEVICE REMAINS IMPLANTED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507978 SPEEDTRIAD COMPRESSION IMPLANT KIT 18X15X8MM CENTERED STAPLE,FIXATION,BONE JDR BIO MEDICAL ENTERPRISES INC BMESE155223

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention