MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-03 for CRANIOS REINFORCED FAST SET PUTTY 5CC-STERILE 615.05.01S manufactured by Synthes Monument.
[66769109]
(b)(4). Due to intra-operative issues, the device was not implanted/explanted. Complainant part is expected to be returned for manufacturer review/investigation, as the device was reportedly discarded by the facility. Part 615. 05. 01s, lot dsd5873: release to warehouse date: august 15, 2016. Expiration date: september 28, 2017. Supplier: (b)(4). No non-conformance reports were generated during production. Review of device history records showed that there were no issues during the manufacture of this product that would contribute to this complaint condition. 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
[66769110]
It was reported that the patient underwent surgery for a cranial defect repair on (b)(6) 2017 and during the procedure the bone cement (cranios) hardened but did not adhere to the bone. The cranios biomaterial was removed and a non-synthes product was being implanted to complete the procedure. As a result of these events there was a surgical delay of an unspecified length. The patient outcome was reported as stable. It was reported that the cranios had been stored at room temperature and the expiration date was september 28, 2017. Information was not provided on the time sequence for mixing, implantation and setting of the bone cement. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1719045-2017-10081 |
| MDR Report Key | 6299797 |
| Date Received | 2017-02-03 |
| Date of Report | 2017-01-12 |
| Date of Event | 2017-01-12 |
| Date Mfgr Received | 2017-01-12 |
| Device Manufacturer Date | 2016-08-15 |
| Date Added to Maude | 2017-02-03 |
| 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 | 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 | SYNTHES MONUMENT |
| Manufacturer Street | 1051 SYNTHES AVE |
| 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 | 0 |
| Brand Name | CRANIOS REINFORCED FAST SET PUTTY 5CC-STERILE |
| Generic Name | METHYL METHACRYLATE FOR CRANIPLASTY |
| Product Code | GXP |
| Date Received | 2017-02-03 |
| Catalog Number | 615.05.01S |
| Lot Number | DSD5873 |
| Device Expiration Date | 2017-09-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES MONUMENT |
| Manufacturer Address | 1051 SYNTHES AVE MONUMENT CO 80132 US 80132 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-03 |