MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2014-01-17 for ECD H24-33 PEEK 891.302 manufactured by Synthes Gmbh.
[20010861]
Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported on (b)(6); that during the surgery on (b)(6) 2013 that upon insertion of the expandable corpectomy device intraoperatively, the device would not expand. The threads on the mechanism of the device were worn and therefore the distractor was unable to open up the device. The wheel on the distractor had flattened the teeth on the device. The surgery time was extended 30 mins. This is report 1 of 1 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[20485633]
Device was used for treatment, not diagnosis. Device is an implant. Device is not distributed in the united states, but is similar to device marketed in the usa. Investigation could not be completed and no conclusion could be drawn as no device was returned. A review of device history records was performed and no complaint related issues were found during manufacturing that would contribute to this complaint. Placeholder.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030965-2014-00034 |
| MDR Report Key | 3581220 |
| Report Source | 01,05,07 |
| Date Received | 2014-01-17 |
| Date of Report | 2013-12-20 |
| Date of Event | 2013-12-18 |
| Date Mfgr Received | 2013-12-20 |
| Device Manufacturer Date | 2012-12-21 |
| Date Added to Maude | 2014-04-18 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | GABRIEL SZASZ |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 8006207025 |
| Manufacturer G1 | SYNTHES GMBH |
| Manufacturer Street | EIMATTSTRASSE 3 CH-4436 |
| Manufacturer City | OBERDORF |
| Manufacturer Country | SZ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ECD H24-33 PEEK |
| Product Code | MOP |
| Date Received | 2014-01-17 |
| Catalog Number | 891.302 |
| Lot Number | AA2569 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES GMBH |
| Manufacturer Address | EIMATTSTRASSE 3 CH-4436 OBERDORF SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-01-17 |