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 2016-10-06 for CRANIOS REINFORCED FAST SET PUTTY 10CC-STERILE 615.10.01S manufactured by Synthes Usa.
[56592990]
Device was used for treatment, not diagnosis. (b)(4). 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. 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
[56592991]
It was reported a patient underwent a cranioplasty procedure on (b)(6) 2016, and was implanted with cranios fast set putty, sterile, 0. 4mm titanium matrixneuro reconstruction mesh, and eight (8) titanium matrixmidface screws, self-drilling. On (b)(6) 2016, the patient was returned to the operating room to remove the mesh due to an infection, specifically a hole in the skin where the cranios putty was implanted. Debridement was required. There was no surgical delay reported. The procedure was completed successfully. This is report 1 of 10 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2520274-2016-14802 |
| MDR Report Key | 6002644 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-10-06 |
| Date of Report | 2016-09-19 |
| Date Mfgr Received | 2016-09-19 |
| Date Added to Maude | 2016-10-06 |
| 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 | MARK VORNHEDER |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRANIOS REINFORCED FAST SET PUTTY 10CC-STERILE |
| Generic Name | METHYL METHACRYLATE FOR CRANIOPLASTY |
| Product Code | GXP |
| Date Received | 2016-10-06 |
| Catalog Number | 615.10.01S |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES USA |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-10-06 |