MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2012-08-15 for CRIMPER F/TRANSV-ONNECTORS 388.038 manufactured by Synthes Gmbh.
[18805493]
The investigation could not be completed; no conclusion could be drawn, as no product was received.
Patient Sequence No: 1, Text Type: N, H10
[18978055]
A device report from (b)(6) indicated a hosp in (b)(6) reported: pt who had a cervical dislocation bone fracture was being treated with posterior cervical spinal fusion using the synapse and inserted ps to c5-th2. During the addition of a transconnector at final fixation the edge of the crimper broke and went into the pt. Surgeon was unaware of the crimper breaking during the procedure and it was found after the procedure on post op x-rays. Surgeon returned the pt to the operating room and removed the broken piece of the crimper. Surgeon noted he did not feel the crimper breaking.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2012-00642 |
| MDR Report Key | 2705816 |
| Report Source | 01 |
| Date Received | 2012-08-15 |
| Date of Report | 2012-07-18 |
| Date of Event | 2012-06-27 |
| Date Mfgr Received | 2012-07-18 |
| Date Added to Maude | 2012-08-21 |
| 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 | MS SHERRY LAING |
| 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 |
| Manufacturer City | OBERDORF CH-4436 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH-4436 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRIMPER F/TRANSV-ONNECTORS |
| Generic Name | CRIMPER |
| Product Code | HXS |
| Date Received | 2012-08-15 |
| Catalog Number | 388.038 |
| Lot Number | T941969 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES GMBH |
| Manufacturer Address | OBERDORF |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-08-15 |