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 2017-10-10 for CRANIOS REINFORCED FAST SET PUTTY 10CC-STERILE 615.10.01S manufactured by Synthes Monument.
[89178109]
(b)(4). Device is not expected to be returned for manufacturer review/investigation. The patient underwent emergency bring-back surgery on (b)(6) 2017 to remove the product "cranios reinforced fast set putty 10cc-sterile" after experiencing numbness in extremities and compression on spinal cord postoperatively. Based on the (cqcchart) decision, off-label used in the procedure as the device malfunction causing serious injury leading to revision surgery. Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was not returned and no lot number was provided. Based on the information available, this complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. 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
[89178110]
It was reported that the patient underwent removal of cranios reinforced fast set putty on (b)(6) 2017 due to numbness in her extremities and compression on spinal cord. The patient was originally implanted with the product during a thoracic laminectomy procedure on (b)(6) 2017. Bone cement was needed during the procedure; therefore, a 10cc box of cranios was opened. It was reported that the bone cement worked as intended and did not malfunction. An unknown amount of the product was implanted in the patient. The patient underwent emergency bring-back surgery on (b)(6) 2017 to remove the product after experiencing numbness in extremities and compression on spinal cord postoperatively. To the sales consultant? S knowledge, all of the bone cement was able to be removed and was not replaced with anything. The surgery was successfully completed with no surgical delay. The patient is now in stable condition and is regaining feeling. There is no information about patient's disease history, but it was reported that the patient was in an otherwise healthy condition. This complaint involves one (1) device. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1719045-2017-11043 |
| MDR Report Key | 6936841 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-10-10 |
| Date of Report | 2017-09-25 |
| Date of Event | 2017-09-24 |
| Date Mfgr Received | 2017-09-25 |
| Date Added to Maude | 2017-10-10 |
| 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 |
| 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 | 2017-10-10 |
| 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 MONUMENT |
| Manufacturer Address | 1051 SYNTHES AVE MONUMENT CO 80132 US 80132 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-10-10 |