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 2018-09-04 for TI MATRIXNEURO SCREW SELF-DRILLING 4MM 04.503.104.01 manufactured by Wrights Lane Synthes Usa Products Llc.
[119058745]
Patient information not available for reporting. Date patient infection began is not known. Additional product codes: jey, gwo. Date of implant is not known. Complainant part is not expected to be returned for manufacturer review/investigation. Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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
[119058746]
It was reported patient was implanted with one (1) patient specific implant (psi) polyetheretherketone (peek) implant, fifteen (15) matrixneuro screws, and four (4) matrixneuro box plates on unknown date. On unknown date it was determined patient had developed an infection at the implant site. Patient was returned to surgery on (b)(6) 2018 where all hardware was removed. It is not known if additional hardware was implanted. No further information was provided. Due to system limitations, this report will address the psi peek implant and nine (9) of the screws. The remaining devices are addressed in (b)(4). This report is for one (1) matrixneuro screw. This is report 5 of 10 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2018-53588 |
| MDR Report Key | 7842165 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-09-04 |
| Date of Report | 2018-08-09 |
| Date Mfgr Received | 2018-08-09 |
| Date Added to Maude | 2018-09-04 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHT LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | MONUMENT |
| Manufacturer Street | 1101 SYNTHES AVENUE |
| Manufacturer City | MONUMENT CO 80132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TI MATRIXNEURO SCREW SELF-DRILLING 4MM |
| Generic Name | COVER, BURR HOLE |
| Product Code | GXR |
| Date Received | 2018-09-04 |
| Model Number | 04.503.104.01 |
| Catalog Number | 04.503.104.01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-09-04 |