PSI SD420.526 TITANIUM IMPLANT

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 2020-01-13 for PSI SD420.526 TITANIUM IMPLANT manufactured by Wrights Lane Synthes Usa Products Llc.

Event Text Entries

[176968878] Complainant part is not expected to be returned for manufacturer review/investigation. Reporter is j&j employee. (b)(4). 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


[176968879] It was reported on (b)(6) 2019, a patient-specific implant (psi) manufactured by depuy synthes was not manufactured to the specifications for a psi case. Through emails the design was confirmed to have holes drilled into the titanium implant to fit a ti matrixneuro box plate (04. 503. 073) but it was manufactured with drill holes spaced for ti matrixneuro box plate (04. 503. 065). Luckily surgeon was able to find 4 x 04. 503. 065 from the other trays and the surgeon and patient were happy but this could have gone very wrong. It is unknown if there were a procedure and patient involvement. This is report 1 of 1 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2939274-2020-00145
MDR Report Key9582021
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-01-13
Date of Report2019-12-17
Date of Event2019-12-16
Date Mfgr Received2020-03-26
Date Added to Maude2020-01-13
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 WRIGHTS LANE EAST
Manufacturer CityWEST CHESTER PA 19380
Manufacturer CountryUS
Manufacturer Postal19380
Manufacturer Phone6103142063
Manufacturer G1BRANDYWINE
Manufacturer Street1303 GOSHEN PARKWAY
Manufacturer CityWEST CHESTER PA 19380
Manufacturer CountryUS
Manufacturer Postal Code19380
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePSI SD420.526 TITANIUM IMPLANT
Generic NamePLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE
Product CodeGXN
Date Received2020-01-13
Model NumberSD420.526
Catalog NumberSD420.526
Lot Number29P5916
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
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 2020-01-13

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