FDA Adverse Event
Malfunction
Summary report: N
STERNAL ZIPFIX WITH NEEDLE STERILE / 5 PACK
MDR report key: 3110695
·
Received May 14, 2013
Report
- Report Number
- 8030965-2013-02186
- Event Type
- Malfunction
- Date Received
- May 14, 2013
- Date of Event
- June 11, 2012
- Report Date
- June 21, 2012
- Manufacturer
- SYNTHES GMBH
- Product Code
- JDQ
- PMA / PMN Number
- K110789
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION OBTAINED FROM RETURNED PRODUCT QUESTIONNAIRE. PLACEHOLDER.
Description of Event or Problem · 1
DURING A STERNAL CLOSURE PROCEDURE ON (B)(6) 2012, THE SURGEON INSERTED THE ZIPFIX AND THE ZIPFIX BECAME LOOSE AFTER TIGHTENING. THE SURGEON CUT THE ZIPFIX AND REMOVED IT. THE PROCEDURE WAS COMPLETED WITH NO FURTHER PROBLEMS. NO ADVERSE EFFECT TO THE PATIENT WAS REPORTED. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).
Description of Event or Problem · 1
SURGEON REPORTED THAT NO PRESCRIPTION/TREATMENT WAS NEEDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 213433 | STERNAL ZIPFIX WITH NEEDLE STERILE / 5 PACK | JDQ | SYNTHES GMBH | 7795456 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |