MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2015-01-30 for IMPLANT, FIXATION DEVICE, SPINAL manufactured by Synthes (usa).
[5403539]
It was reported that during a presentation for the national spine meeting, one of the slides stated the following:? Patient implanted with rod construct experienced a rod breakage post-operatively. Surgeon presenting noted that the patient returned to the operating room for revision surgery.? No additional information was provided. It is not known if the broken rod was a synthes device. This report is for one unknown spinal rod. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[12795244]
Device was used for treatment, not diagnosis. Patient information is unknown. This report is for one unknown spinal rod. Implant and explant dates are unknown. 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
[20065351]
Per surgeon, the patient was referred to him by another surgeon. The patient had revision surgery to stabilize the construct. No parts removed. Surgeon stated the patient is ill and will not tolerate a major surgery. Surgeon also stated the original surgeon does not routinely use depuy or synthes parts and he thinks it is highly unlikely such parts were used with the original surgery.
Patient Sequence No: 1, Text Type: D, B5
[20253301]
Additional narrative: 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
| Report Number | 2520274-2015-10670 |
| MDR Report Key | 4471523 |
| Report Source | 07 |
| Date Received | 2015-01-30 |
| Date of Report | 2015-01-16 |
| Date Mfgr Received | 2015-02-09 |
| Date Added to Maude | 2015-01-30 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LINDA PLEWS |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer Country | US |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | IMPLANT, FIXATION DEVICE, SPINAL |
| Product Code | JDN |
| Date Received | 2015-01-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2015-01-30 |