MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2007-04-27 for AIMING DEVICE 13.5MM/15MM SD388.870 manufactured by Synthes (usa).
[3155289]
A very small piece of the tip of the aiming device broke off in an implant intraoperatively and surgeon elected not to attempt retrieval.
Patient Sequence No: 1, Text Type: D, B5
[10437651]
This info was not provided during initial report. Add'l info has been requested. Device has been rec'd and investigation is in progress.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2530088-2007-00033 |
| MDR Report Key | 2948156 |
| Report Source | 05,07 |
| Date Received | 2007-04-27 |
| Date of Report | 2007-03-30 |
| Date of Event | 2007-03-30 |
| Date Mfgr Received | 2007-03-30 |
| Device Manufacturer Date | 2007-01-01 |
| Date Added to Maude | 2013-02-11 |
| 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 | ELIZABETH SUDMEYER |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 8006207025 |
| Manufacturer G1 | SYNTHES USA |
| Manufacturer Street | 1303 GOSHEN PARKWAY |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19380 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AIMING DEVICE 13.5MM/15MM |
| Generic Name | AIMING DEVICE |
| Product Code | HXO |
| Date Received | 2007-04-27 |
| Model Number | NA |
| Catalog Number | SD388.870 |
| Lot Number | 5407677 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES (USA) |
| Manufacturer Address | WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-04-27 |