MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2013-04-12 for SILHOUETTE RODS GENERIC manufactured by Zimmer Spine.
[18855458]
It was reported that post-operative rod breakage occurred. Pt underwent spinal fixation using silhouette instrumentation in (b)(6) 1999. In (b)(6) 2012, the pt was involved in a motor vehicle accident in which she was rear-ended. X-rays taken after the accident revealed the rod on the right side of the construct was broken in the middle. The pt underwent revision surgery in (b)(6) 2013, at which time adjacent level decompression was performed and the construct was removed with no new instrumentation added.
Patient Sequence No: 1, Text Type: D, B5
[19215143]
It is indicated that the device will not be returned for eval; therefore, a failure analysis of the complaint device could not be completed. The batch number is unk and the manufacturing records for the complaint device could not be reviewed. The most probable root cause is excessive stress to the implant as a result of a motor vehicle accident. This is the final report that will be submitted associated with this incident and device. No additional action is required at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184052-2013-00017 |
| MDR Report Key | 3062935 |
| Report Source | 08 |
| Date Received | 2013-04-12 |
| Date of Report | 2013-03-14 |
| Date of Event | 2012-07-01 |
| Date Mfgr Received | 2013-03-14 |
| Date Added to Maude | 2013-04-18 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | SCOTT LAPOINTE |
| Manufacturer Street | 7375 BUSH LAKE RD. |
| Manufacturer City | MINNEAPOLIS MN 55439 |
| Manufacturer Country | US |
| Manufacturer Postal | 55439 |
| Manufacturer Phone | 9528575636 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SILHOUETTE RODS GENERIC |
| Generic Name | SILHOUETTE RODS GENERIC |
| Product Code | MCV |
| Date Received | 2013-04-12 |
| Model Number | SILHOUETTE RODS GENERIC |
| Catalog Number | SILHOUETTE RODS GENERIC |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER SPINE |
| Manufacturer Address | 7375 BUSH LAKE RD. MINNEAPOLIS MN 55439 US 55439 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2013-04-12 |