UNK - INSERTION INSTRUMENT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2020-02-03 for UNK - INSERTION INSTRUMENT manufactured by Depuy Mitek Llc Us.

Event Text Entries

[187760762] This report is for an unknown. Part and lot number are unknown. Without the specific part number; the udi number and 510-k number are unknown. Complainant part is not expected to be returned for manufacturer review/investigation. Concomitant medical products: unknown. (b)(4). Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or 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).
Patient Sequence No: 1, Text Type: N, H10


[187760803] This is report 1 of 5 for the same event. This report is being filed after the review of the following journal article: dr. Dominik meraner, austria "10 years of arthroscopic latarjet procedure: outcome and complications", indian journal of orthopaedics, volume 53, issue 1, pages 102-110, dr. Dominik meraner, speisinger strasse 109, 1130 vienna, austria. The aim of this study is to evaluate the clinical outcome and complications of the latter procedure, most notably infection rate and nerve damage. Materials and methods: 132 shoulders (106 males/19 females, 68 right/64 left) were included in this retrospective study. Patients were included if treatment was performed for anterior instability and if the patient's instability severity index score was at least 4, or if a revision procedure was performed after a prior unsuccessful arthroscopic or open capsule and labral repair. The devices involved were: depuy mitek latarjet instruments, fms duo, (depuy-synthes), shaver and vapr (depuy-synthes). Complications mentioned in the case report were: hematoma, re-operation, broken k-wire, joint instability.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1221934-2020-00418
MDR Report Key9659606
Report SourceFOREIGN,HEALTH PROFESSIONAL,L
Date Received2020-02-03
Date of Report2020-01-22
Date of Event2019-01-01
Date Mfgr Received2020-02-18
Date Added to Maude2020-02-03
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKARA DITTY-BOVARD
Manufacturer Street325 PARAMOUNT DRIVE
Manufacturer CityRAYNHAM MA 02767
Manufacturer CountryUS
Manufacturer Postal02767
Manufacturer Phone6013142063
Manufacturer G1DEPUY MITEK LLC US
Manufacturer Street325 PARAMOUNT DRIVE
Manufacturer CityRAYNHAM MA 02767
Manufacturer CountryUS
Manufacturer Postal Code02767
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNK - INSERTION INSTRUMENT
Generic NameUNK - INSERTION INSTRUMENT
Product CodeFSM
Date Received2020-02-03
Catalog NumberUNK - INSERTION INSTRUMENT
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDEPUY MITEK LLC US
Manufacturer Address325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-03

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