STD BRL 4-HOLE PLATE 135 DEG 2110-135-004

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-14 for STD BRL 4-HOLE PLATE 135 DEG 2110-135-004 manufactured by ..

Event Text Entries

[120540784] (b)(4). Udi - (b)(4). Medical product - std brl lag scrw 12. 5x115mm , item 236115 lot 2017010792. Report source, foreign - event occurred in (b)(6). 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: 3002806535-2018-01082.
Patient Sequence No: 1, Text Type: N, H10


[120540785] The hiploc plate hole is too small for the screw to go through.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3002806535-2018-01083
MDR Report Key7876110
Date Received2018-09-14
Date of Report2018-12-12
Date of Event2018-07-01
Date Mfgr Received2018-12-11
Device Manufacturer Date2017-12-15
Date Added to Maude2018-09-14
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 ContactMS. CHRISTINA ARNT
Manufacturer Street56 E. BELL DR.
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal46582
Manufacturer Phone5745273773
Manufacturer G1BIOMET UK LTD.
Manufacturer StreetWATERTON INDUSTRIAL ESTATES
Manufacturer CityBRIDGEND CF313XA
Manufacturer CountryUK
Manufacturer Postal CodeCF31 3XA
Single Use3
Previous Use Code3
Removal Correction NumberZFA-2018-00210
Event Type3
Type of Report0

Device Details

Brand NameSTD BRL 4-HOLE PLATE 135 DEG
Product CodeJDO
Date Received2018-09-14
Catalog Number2110-135-004
Lot Number6192491
OperatorHEALTH PROFESSIONAL
Device Availability*
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
Manufacturer.
Manufacturer AddressWATERTON INDUSTRIAL ESTATES BRIDGEND CF313XA UK CF31 3XA


Patients

Patient NumberTreatmentOutcomeDate
10 2018-09-14

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