BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HALLU LOCK PLATE UNSPECIFIED DIMENSIONS

    MDR report key: 5003175 · Received August 11, 2015

    Report

    Report Number
    9615741-2015-00042
    Event Type
    Injury
    Date Received
    August 11, 2015
    Report Date
    July 14, 2015
    Manufacturer
    NEWDEAL SAS
    Product Code
    HRS
    PMA / PMN Number
    K083154
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Additional Manufacturer Narrative · 1

    INTEGRA COMPLETED THEIR INTERNAL INVESTIGATION ON 09/01/2015: METHODS: EVALUATION OF ACTUAL DEVICE; DEVICE HISTORY REVIEW; COMPLAINTS HISTORY REVIEW. RESULTS: THE DEVICE WAS NOT RETURNED FOR EVALUATION. AS NOT PRODUCT ID AND NO MANUFACTURING LOT ARE PROVIDED, NO PRODUCT FROM SAME MANUFACTURING LOT CAN BE TAKEN IN INVENTORY FOR TESTING. IN CONCLUSION, NO FAILURE ANALYSIS IS POSSIBLE. A REVIEW OF THE DESIGN SPECIFICATIONS AND DESIGN CHANGES HISTORY CANNOT BE PERFORMED AS NO PRODUCT ID OR MANUFACTURING LOT ARE PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD CANNOT BE DONE AS NO MANUFACTURING LOT IS PROVIDED. PRIOR TO RELEASE, FOLLOWING FREQUENCY DETERMINED BY PROBABILITY LAW APPLIED TO INCOMING INSPECTION, HALLU® LOCK PLATES ARE TESTED FOR: VISUAL ASPECT: LASER MARKING, ANODIZING COLOR AND GENERAL ASPECT. DOCUMENTARY INSPECTION: MEASUREMENT REPORT, RAW MATERIAL CERTIFICATE, INSTRUCTIONS FOR USE, STERILIZATION CERTIFICATE AND LABELS. -FUNCTIONAL INSPECTION: WIRE HOLES DIAMETERS AND THREADED HOLES DIAMETERS. -DIMENSIONAL INSPECTION: TOTAL LENGTH (HALLU®-LOCK C PLATE ONLY), THICKNESS. PRIOR TO RELEASE, FOLLOWING FREQUENCY DETERMINED BY PROBABILITY LAW APPLIED TO INCOMING INSPECTION, SURFIX® LOCKING SYSTEM SCREWS AND LOCK-SCREWS (2.7MM OR 3.0MM DIAMETER) ARE TESTED FOR: VISUAL ASPECT: LASER MARKING, ANODIZING COLOR AND GENERAL ASPECT. DOCUMENTARY INSPECTION: MEASUREMENT REPORT, RAW MATERIAL CERTIFICATE, INSTRUCTIONS FOR USE, STERILIZATION CERTIFICATE AND LABELS. FUNCTIONAL INSPECTION: HEXALOBULAR PRINT CHECKED WITH A CALIBRATED GO/NO GO HEXALOBULAR SIZE 7 DIMENSIONAL INSPECTION: TOTAL LENGTH (SCREW), THICKNESS (LOCK-SCREW), SCREW HEAD DIAMETER, LOCK SCREW DIAMETER AND EXTERNAL THREADED DIAMETER (SCREW AND LOCK-SCREW). REGARDING DISCOMFORT, EXTERNAL DIMENSIONS OF THE IMPLANTS (SUCH AS EXTERNAL DIAMETERS OF SCREWS OR LOCK-SCREWS, THICKNESS OF THE PLATE AND LOCK-SCREWS) AND PRESENCE OF CUTTING FACES CAN BE FOUND AS ROOT CAUSE. REGARDING INSPECTION REQUIREMENTS, THESE SPECIFICATIONS ARE CHECKED DURING VISUAL OR DIMENSIONAL CHECK PRIOR TO RELEASE. A REVIEW OF THE COMPLAINT SYSTEM WAS PERFORMED. THIS IS THE (B)(4) INCIDENT REPORTED TO NEWDEAL ABOUT A DISCOMFORT AFTER HALLU-LOCK PLATES AND SCREWS IMPLANTATION FOR THE PAST TWO YEARS. DURING THE SAME TIME PERIOD, (B)(4) HALLU-LOCK PLATES WERE SOLD. PER CONSEQUENCE, THE COMPLAINT RATE FOR THIS KIND OF INCIDENT DURING THE STATED TIME PERIOD IS (B)(4). CONCLUSION: GIVEN THE DESCRIPTION OF THE EVENT, THE OBSERVATIONS DURING THE INVESTIGATION AND THE LACK OF PRODUCT INFORMATION OR PRODUCT RETURN, THE ROOT CAUSE CANNOT BE FOUND.

    Description of Event or Problem · 1

    THIS IS THE 2ND OF 2 REPORTS FOR THE SAME EVENT, DIFFERENT DEVICE. IT WAS REPORTED THE DEVICE WAS IMPLANTED 5 YEARS AGO. THE REMOVAL OF THE OSTEOTOMY MATERIAL WAS PERFORMED AS THE PATIENT FELT DISCOMFORT W/THE SCREW & PLATE IMPLANTED 5 YEARS AGO. THIS EVENT WAS CAPTURED DUE TO THE NOTIFICATION OF THE REMOVAL OF THE DEVICES. THE CUSTOMER DID NOT INITIATE A COMPLAINT AGAINST THESE DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523882 HALLU LOCK PLATE UNSPECIFIED DIMENSIONS HALLU LOCK HRS NEWDEAL SAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention