BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LACTO SCR 2.0X7MM 2.0 SYS 2/PK

    MDR report key: 13013758 · Received December 15, 2021

    Report

    Report Number
    0001032347-2021-00584
    Event Type
    Injury
    Date Received
    December 15, 2021
    Date of Event
    December 23, 2021
    Report Date
    April 28, 2022
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    UDI-DI
    00841036055028
    PMA / PMN Number
    K002083
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: L-PLT RT REG 2.0 LACTOSORB SYS, CAT# 915-2101, LOT# 181330; L-PLT LT REG 2.0 LACTOSORB SYS, CAT# 915-2102, LOT# 308570; QTY: 7 OF LACTO SCR 2.0X7MM 2.0 SYS 2/PK, CAT# 915-2301, LOT# 480430. REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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: 0001032347-2021-00582, 0001032347-2021-00583, 0001032347-2021-00585, 0001032347-2021-00586, 0001032347-2021-00587, 0001032347-2021-00588, 0001032347-2021-00589, 0001032347-2021-00590, 001032347-2021-00591.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B2, B3, B4, B5, D6, G3, G6, H2, H6, H10.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT EXPERIENCED SWELLING APPROXIMATELY 8 MONTHS AFTER A PIRIFORM APERTURE WITH LACTOSORB FOR MAXILLARY OSTEOTOMY. THE PATIENT HAS INDICATED FOR A REVISION, ALTHOUGH IT HAS YET TO OCCUR. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDWERWENT A REVISION PROCEDURE APPROXIMATELY 8 MONTHS AFTER A PIRIFORM APERTURE WITH LACTOSORB FOR MAXILLARY OSTEOTOMY DUE TO SWELLING. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1906871 LACTO SCR 2.0X7MM 2.0 SYS 2/PK CRANIOFACIAL BONE SCREW, BIOABSORBABLE JEY BIOMET MICROFIXATION NI 480430 00841036055028

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| H| R SEE H10