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.
[113561958]
Patient age, date of birth, and weight not available for reporting. Date patient infection began is not known. 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
[113561959]
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 1 of 5 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2939274-2018-52779 |
MDR Report Key | 7674402 |
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 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 | 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 |