MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-07-10 for TI MATRIXNEURO SCREW SELF-DRILLING 4MM 04.503.104.01 manufactured by Wrights Lane Synthes Usa Products Llc.
[113569379]
Patient age, date of birth, and weight not available for reporting. Date patient infection began is not known. Additional product codes: jey, gxr. Date of explant reported as one month after implant, exact date 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
[113569380]
It was reported that on (b)(6) 2018, the patient was implanted with two (2) polyetheretherketone (peek) patient-specific implants (psi), a total of eight (8) matrixneuro plates (4 for each psi implant) and sixteen (16) matrixneuro screws during a bifrontal cranioplasty. After approximately one (1) month, implants were removed due to infection. The hardware removal was successfully completed on an unknown date. Revision surgery will be scheduled to insert a new flap once patient heals from infection. Patient outcome was satisfactory. This report is for one (1) titanium matrixneuro screw 4mm. This is report 4 of 5 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2018-52782 |
| MDR Report Key | 7674572 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-07-10 |
| Date of Report | 2018-05-04 |
| Date Mfgr Received | 2018-05-04 |
| Date Added to Maude | 2018-07-10 |
| 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 WRIGHTS 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 | PLATE,CRANIOPLASTY,PREFORMED, ALTERABLE |
| Product Code | GWO |
| Date Received | 2018-07-10 |
| 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 | 2018-07-10 |