2.0MM RAPID RESORBABLE CORTEX SCREW 4MM-STERILE 806.004.10S

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-24 for 2.0MM RAPID RESORBABLE CORTEX SCREW 4MM-STERILE 806.004.10S manufactured by Wrights Lane Synthes Usa Products Llc.

Event Text Entries

[181800006] Complainant part is expected to be returned for manufacturer review/ investigation, but has yet to be received. 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. (b)(4). 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


[181800007] It was reported that on (b)(6) 2020 the patient had a cranial vault reconstruction surgery. The patient was taken back to the on (b)(6) 2020 for removal of the affected plate. After the incision/ exposure of the affected area it was determined that the plate that buckled was not the 1. 5 mm resorbable strut plate 2 x 36 holes (851. 436. 01s), but instead a 2. 0 mm resorbable strut plate 2 x 18 holes (852. 421. 01s) with 2. 0 mm resorbable cortex screws (8 ea) (806. 004. 10s). The gap in the bone that plate spanned was 15mm. The surgeon used a periosteal elevator to pry the plate off of the bone for removal and as a result he broke the plate in half and sheared the screws. Upon removal of the affected plate/ screws the wound was debrided, irrigated, and closed. It is unknown if there was a surgical delay. The procedure and patient status is unknown. This report is for one 2. 0 mm rapid resorbable cortex screw 4 mm-sterile. This is report 2 of 3 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2939274-2020-01008
MDR Report Key9744205
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-02-24
Date of Report2020-02-01
Date of Event2020-02-01
Date Mfgr Received2020-04-01
Device Manufacturer Date2019-11-13
Date Added to Maude2020-02-24
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 Street1302 WRIGHTS LANE EAST
Manufacturer CityWEST CHESTER PA 19380
Manufacturer CountryUS
Manufacturer Postal19380
Manufacturer Phone6103142063
Manufacturer G1WERK BIO OBERDORF (CH)
Manufacturer StreetEIMATTSTRASSE 3
Manufacturer CityOBERDORF 4436
Manufacturer CountrySZ
Manufacturer Postal Code4436
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name2.0MM RAPID RESORBABLE CORTEX SCREW 4MM-STERILE
Generic NameBONE PLATE
Product CodeJEY
Date Received2020-02-24
Returned To Mfg2020-02-26
Model Number806.004.10S
Catalog Number806.004.10S
Lot Number6L28286
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerWRIGHTS LANE SYNTHES USA PRODUCTS LLC
Manufacturer Address1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-02-24

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