UNK - PLATES: SPINE UNK - PLATES: SPINE-US

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 2020-03-27 for UNK - PLATES: SPINE UNK - PLATES: SPINE-US manufactured by Oberdorf Synthes Produktions Gmbh.

Event Text Entries

[186533711] Product complaint # (b)(4). 510k: this report is for an unknown plate/unknown lot number. Without the specific part number, the udi number and 510k number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. Without a lot number, the device history records review could not be completed as no product was received. The investigation could not be completed; no conclusion could be drawn at the time of filing this report. 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


[186533712] Device report from synthes reports an event in (b)(6) as follows: it was reported that the doctor placed the guide in the hole of the plate and attempted to seat it. He had a little trouble doing this, however managed to seat the pin in the hole of the plate and placed 4 screws. As he lifted the guide out of the last place the pin got stuck and he had to remove the pin with forceps. Surgery was delayed due to the reported event five (5) minutes. Concomitant devices reported: unknown plate (part # unknown, lot # unknown, quantity # 1), unknown screws (part # unknown, lot # unknown, quantity # unknown). This complaint involves one (1) device. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8030965-2020-02353
MDR Report Key9891071
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-27
Date of Report2020-03-01
Date of Event2020-03-02
Date Mfgr Received2020-03-01
Date Added to Maude2020-03-27
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 StreetEIMATTSTRASSE 3
Manufacturer CityOBERDORF 4436
Manufacturer CountrySZ
Manufacturer Postal4436
Manufacturer Phone6103142063
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNK - PLATES: SPINE
Generic NamePLATE, FIXATION, BONE
Product CodeHRS
Date Received2020-03-27
Catalog NumberUNK - PLATES: SPINE-US
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
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 2020-03-27

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