FDA Adverse Event
Injury
Summary report: N
STERNAL ZIPFIX ITH NEEDLE STERILE
MDR report key: 2582474
·
Received May 16, 2012
Report
- Report Number
- 1719045-2012-00517
- Event Type
- Injury
- Date Received
- May 16, 2012
- Report Date
- April 23, 2012
- Manufacturer
- SYNTEHS MONUMENT
- Product Code
- JDQ
- PMA / PMN Number
- K110789
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.
Description of Event or Problem · 1
PT WAS IMPLANTED WITH ZIPFIX ON (B)(6) 2012 AFTER A CORONARY ARTERY BYPASS GRAFT. THE PT STARTED COUGHING AND COMPLAINED OF CHEST PAIN ON AN UNK DATE, POST-OPERATIVE X-RAYS CONFIRMED ALL FIVE OF THE ZIPFIX FELL APART. THE PT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2012, SURGEON REMOVED ALL HARDWARE AND PT WAS REVISED TO WIRES. ALL PRODUCT WAS DISCARDED BY THE HOSPITAL ACCOUNT. THIS IS 3 OF 5 REPORTS FOR THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STERNAL ZIPFIX ITH NEEDLE STERILE | STERNAL ZIPFIX | JDQ | SYNTEHS MONUMENT | 2808513 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention | STERNAL ZIPFIX |