BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LACTOSORB 1.5 MM 6-HOLE CURVED PLATE

    MDR report key: 7106109 · Received December 11, 2017

    Report

    Report Number
    0001032347-2017-00859
    Event Type
    Injury
    Date Received
    December 11, 2017
    Date of Event
    November 24, 2017
    Report Date
    May 22, 2018
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    PMA / PMN Number
    PK955729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THESE PRODUCTS WERE REMOVED IN A REVISION: THEREFORE, THE COMPLAINT IS CONSIDERED CONFIRMED. NO PRODUCT WAS RETURNED AND NO FUNCTIONAL TESTS OR INSPECTIONS COULD BE PERFORMED. NO X-RAYS, SCANS, PICTURES, OR PHYSICIANS REPORTS WERE PROVIDED. NO DETAILS COULD BE GATHERED IN REGARDS TO A POTENTIAL CAUSE OF THE COMPLAINT. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2017-00856-2, 0001032347-2017-00857-2, 0001032347-2017-00858-2, AND 0001032347-2017-00860-2.

    Additional Manufacturer Narrative · 1

    (B)(4). PATIENT EXACT WEIGHT IS REPORTED AS (B)(6) KG. (B)(4). (B)(6) 2017 IS REPORTED AS THE ANTICIPATED DATE OF REVISION; THIS HAS NOT BEEN CONFIRMED. ATTEMPTS HAVE BEEN MADE TO CONFIRM THE REVISION TOOK PLACE AND NO FURTHER INFORMATION HAS BEEN PROVIDED. CONCOMITANT MEDICAL PRODUCT - ZIMMER BIOMET LACTOSORB SCREW 1.5 X 5 MM 1.5 SYSTEM 2-PACK CATALOG #: 915-2316 LOT #:248150, ZIMMER BIOMET LACTOSORB SCREW 1.5 X 5 MM 1.5 SYSTEM 2-PACK CATALOG #: 915-2316 LOT #:248160, ZIMMER BIOMET LACTOSORB 1.5 MM 4-HOLE STRAIGHT PLATE CATALOG #: 915-2413 LOT #:589490, ZIMMER BIOMET LACTOSORB 1.5 MM 6-HOLE STRAIGHT PLATE CATALOG #: 915-2415 LOT #: 38120, THERAPY DATE: (B)(6) 2017. (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO IT BEING STILL IMPLANTED AT THE TIME. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2017-00856 THROUGH 0001032347-2017-00860.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO IT BEING INVESTIGATED BY THE HOSPITAL. THE FOLLOWING SECTIONS WERE UPDATED: DATE OF EVENT, DATE OF THIS REPORT, DESCRIBE EVENT OR PROBLEM, IF EXPLANTED, GIVE DATE, DATE RECEIVED BY MANUFACTURER, TYPE OF REPORT AND FOLLOW-UP NUMBER, TYPE OF FOLLOW-UP, ADDITIONAL NARRATIVES/ DATA. MULTIPLE SUPPLEMENTAL MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2017-00856-1 THROUGH 0001032347-2017-00860-1.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY SIX MONTHS AFTER THE ORIGINAL SURGERY, THE PATIENT RETURNED TO THE HOSPITAL WITH THE COMPLAINT OF PAIN OF THE "CRISTA INFRA-ZYGOMATICA" AND A PART OF THE FRONTAL SUTURE. THE SURGEON PRESCRIBED THE ANTIBIOTIC, KEFURARU 250, 3 TABLETS PER DAY FOR ONE WEEK. AFTER THAT, THE PATIENT VOMITED DUE TO EXCESSIVE PAIN TWO DAYS AFTER BEING PRESCRIBED THE MEDICATION. THE SURGEON INTERRUPTED THE PRESCRIPTION OF THE ANTIBIOTICS AND PRESCRIBED ANODYNE TO THE PATIENT SIX DAYS LATER. THE SURGEON ADVISED THE PAIN OF THE PATIENT WAS REDUCED, BUT THE SYMPTOMS DID NOT CHANGE. THEREFORE, THE SURGEON DECIDED TO PERFORM A REVISION APPROXIMATELY 20 DAYS AFTER PRESCRIBING THE ANODYNE. ATTEMPTS HAVE BEEN MADE TO CONFIRM THE REVISION TOOK PLACE AND NO FURTHER INFORMATION HAS BEEN PROVIDED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS ADDITIONALLY REPORTED THE REVISION SURGERY WAS COMPLETED WITHOUT ANY PROBLEMS. ALTHOUGH MOST OF THE PRODUCTS WERE RESORBED BY THE PATIENT'S BODY, A FEW REMAINED UN-RESORBED. THESE UN-RESORBED PRODUCTS ARE BEING INVESTIGATED AT THE HOSPITAL. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    884089 LACTOSORB 1.5 MM 6-HOLE CURVED PLATE RESORBABLE PLATE, BONE HRS BIOMET MICROFIXATION N/A 164480

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Hospitalization| R