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.
[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
| Report Number | 2939274-2020-00145 |
| MDR Report Key | 9582021 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-13 |
| Date of Report | 2019-12-17 |
| Date of Event | 2019-12-16 |
| Date Mfgr Received | 2020-03-26 |
| Date Added to Maude | 2020-01-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | BRANDYWINE |
| Manufacturer Street | 1303 GOSHEN PARKWAY |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19380 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PSI SD420.526 TITANIUM IMPLANT |
| Generic Name | PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE |
| Product Code | GXN |
| Date Received | 2020-01-13 |
| Model Number | SD420.526 |
| Catalog Number | SD420.526 |
| Lot Number | 29P5916 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WRIGHTS LANE SYNTHES USA PRODUCTS LLC |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-13 |