TI FIXATION PLATE F/CONDYLAR HEAD/2MM 04.449.020

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-01-30 for TI FIXATION PLATE F/CONDYLAR HEAD/2MM 04.449.020 manufactured by Oberdorf Synthes Produktions Gmbh.

Event Text Entries

[134521542] Explanted date: device has not been reported as explanted. Complainant part is not expected to be returned for manufacturer review/investigation. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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. A review of the device history records has been requested. 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.
Patient Sequence No: 1, Text Type: N, H10


[134521543] Device report from synthes (b)(4) reports an event as follows: it was reported that on (b)(6) 2018 a two (2) titanium condylar heads and a slotted screw for conylar head did not fit properly with the patient specific plate for mandible. The surgeon noticed from his last surgery that there was an offset between the plate and the condylar head after fixation with the screws. The screws only did a small rotation to be locked in their position, hence the plate was not well in contact with the condyle. There was no surgical delay reported and did not cause injury or harm to the patient. This report is for a titanium condylar head. This is report 1 of 4 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8030965-2019-60487
MDR Report Key8289282
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-01-30
Date of Report2018-10-19
Date of Event2018-09-21
Date Mfgr Received2019-02-11
Device Manufacturer Date2017-10-23
Date Added to Maude2019-01-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKARA DITTY-BOVARD
Manufacturer Street1302 WRIGHT LANE EAST
Manufacturer CityWEST CHESTER PA 19380
Manufacturer CountryUS
Manufacturer Postal19380
Manufacturer Phone6107195000
Manufacturer G1WERK MEZZOVICO (CH)
Manufacturer StreetVIA CAVAZZ 5
Manufacturer CityMEZZOVICO 6805
Manufacturer CountrySZ
Manufacturer Postal Code6805
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTI FIXATION PLATE F/CONDYLAR HEAD/2MM
Generic NamePROSTHESIS, CONDYLE, MANDIBULAR TEMPORARY
Product CodeNEI
Date Received2019-01-30
Catalog Number04.449.020
Lot NumberL621613
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerOBERDORF SYNTHES PRODUKTIONS GMBH
Manufacturer AddressEIMATTSTRASSE 3 OBERDORF 4436 SZ 4436


Patients

Patient NumberTreatmentOutcomeDate
10 2019-01-30

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