MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2008-04-12 for 1.0MM STERNAL CABLE 750MM 291.911.01S manufactured by Synthes Monument.
[19243907]
A 1. 0mm sternal cables implanted in a patient, broke post operative.
Patient Sequence No: 1, Text Type: D, B5
[19329655]
No investigation could be performed, no conclusion could be drawn as no device was returned. Synthes is unable to determine the manufacture date without a lot number.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1719045-2008-00061 |
| MDR Report Key | 1044755 |
| Report Source | 05,07 |
| Date Received | 2008-04-12 |
| Date of Report | 2008-04-17 |
| Date Mfgr Received | 2008-04-17 |
| Date Added to Maude | 2009-08-11 |
| 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 | JODI TEMPLE |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 8006207025 |
| Manufacturer G1 | SYNTHES MONUMENT |
| Manufacturer Street | 1101 SYNTHES AVENUE |
| Manufacturer City | MONUMENT CO 80132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 1.0MM STERNAL CABLE 750MM |
| Generic Name | STERNAL CABLES |
| Product Code | DZK |
| Date Received | 2008-04-12 |
| Model Number | NA |
| Catalog Number | 291.911.01S |
| Lot Number | NI |
| ID Number | NA |
| 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 MONUMENT |
| Manufacturer Address | MONUMENT CO 80132 US 80132 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-04-12 |