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 2017-05-16 for CRANIOS REINFORCED FAST SET PUTTY 10CC-STERILE 615.10.01S manufactured by Synthes Monument.
[75305662]
(b)(4). Device is not expected to be returned for manufacturer review/investigation. (b)(4). A device history record (dhr) review was performed on part# 615. 10. 01s lot# dsd5973: release to warehouse date: 06-sep-2016, expiration date: 28-sep-2017, supplier: (b)(4): no non conformance reports (ncrs) were generated during production. Review of the device history record 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
[75305663]
It was reported that a cranioplasty for a cranial defect occurred on (b)(6) 2017 and it was discovered that the cranios bone cement popped out in one piece postoperatively following the cranioplasty. Prior to placing the cement, the surgeon needed to remove some necrotic brain tissue. After placement of the cement, the cement cured successfully. Twenty-four hours postoperatively, the patient developed a cerebrospinal fluid (csf) leak which increased the intracranial pressure (icp) in the skull. When the surgeon went back in to fix the csf leak, it was discovered that the cement had popped out in one piece. There was no patient harm. The sales consultant stated that it takes 48 hours for the cement to cure and the cement was not fully cured at that point. The surgeon felt the issue was due to the csf leak and not due the cranios cement. The surgeon repaired the leak, removed the cement and reconstructed with a synthes titanium mesh on (b)(6) 2017. The patient outcome was reported as fine. This report is for one (1) cranios reinforced fast set putty 10cc-sterile. This is report 1 of 2 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1719045-2017-10468 |
| MDR Report Key | 6568659 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-05-16 |
| Date of Report | 2017-04-18 |
| Date Mfgr Received | 2017-04-18 |
| Device Manufacturer Date | 2016-09-06 |
| Date Added to Maude | 2017-05-16 |
| 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 | 3 |
| Brand Name | CRANIOS REINFORCED FAST SET PUTTY 10CC-STERILE |
| Generic Name | METHYL METHACRYLATE FOR CRANIPLASTY |
| Product Code | GXP |
| Date Received | 2017-05-16 |
| Catalog Number | 615.10.01S |
| Lot Number | DSD5973 |
| 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 | 1. Required No Informationntervention | 2017-05-16 |