MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2012-12-20 for WIRE manufactured by Synthes Usa.
[15099645]
Patient had a triple coronary artery bypass graft procedure performed on (b)(6) 2012. The same day, as the patient was still present at the hospital, the patient heard a pop sound and notified medical staff. It was determined that the patient had opened back up underneath the staples. Patient was slender in size. The patient returned to the operating room on (b)(6) 2012 and the four zipfix and two double wires that had broken were removed. The surgeon revised the patient with a combination of single and double wires. This is 6 of 6 reports for this event.
Patient Sequence No: 1, Text Type: D, B5
[15273118]
Device was used for treatment, not diagnosis. 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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2012-04264 |
| MDR Report Key | 2882866 |
| Report Source | 05,07 |
| Date Received | 2012-12-20 |
| Date of Report | 2012-11-22 |
| Date of Event | 2012-09-28 |
| Date Mfgr Received | 2012-11-22 |
| Date Added to Maude | 2012-12-21 |
| 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 | KUBA ZAROBKIEWICZ |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 8006207025 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | WIRE |
| Product Code | DYX |
| Date Received | 2012-12-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES USA |
| Manufacturer Address | WEST CHESTER PA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-12-20 |