T-PLIF IMPLANT HOLDER 389.266

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-10-24 for T-PLIF IMPLANT HOLDER 389.266 manufactured by Wrights Lane Synthes Usa Products Llc.

Event Text Entries

[125445334] Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Initial reporter is synthes sales representative. 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. 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


[125445335] It was reported that on (b)(6) 2018 a patient underwent posterior spinal fusion when the t-plif implant holder broke intra-operatively. It is unknown if there were fragments from the device. There was no patient consequence. The procedure outcome is unknown. This report is for one (1) t-plif implant holder. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2939274-2018-54570
MDR Report Key7999754
Report SourceCOMPANY REPRESENTATIVE
Date Received2018-10-24
Date of Report2018-10-09
Date of Event2018-10-08
Date Mfgr Received2018-11-30
Device Manufacturer Date2007-07-31
Date Added to Maude2018-10-24
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 ContactMICHAEL COTE
Manufacturer Street1302 WRIGHT LANE EAST
Manufacturer CityWEST CHESTER PA 19380
Manufacturer CountryUS
Manufacturer Postal19380
Manufacturer Phone6107195000
Manufacturer G1SYNTHES TUTTLINGEN
Manufacturer StreetUNTER HASSLEN 5
Manufacturer CityTUTTLINGEN 78532
Manufacturer CountryGM
Manufacturer Postal Code78532
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameT-PLIF IMPLANT HOLDER
Generic NameFORCEPS,GEN & PLASTIC SURGERY
Product CodeGEN
Date Received2018-10-24
Returned To Mfg2018-10-30
Model Number389.266
Catalog Number389.266
Lot NumberA7QA05
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
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
10 2018-10-24

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