FDA Adverse Event
Malfunction
Summary report: N
CHRONOS STRIP 100*25*3
MDR report key: 2826224
·
Received October 4, 2012
Report
- Report Number
- 1719045-2012-01019
- Event Type
- Malfunction
- Date Received
- October 4, 2012
- Date of Event
- September 4, 2012
- Report Date
- September 5, 2012
- Manufacturer
- SYNTHES MONUMENT
- Product Code
- MQV
- PMA / PMN Number
- K071046
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE USED FOR TREATMENT. THE CHRONOS STRIP, 100MM X 25MM X 3MM, B-TCP, STERILE-(B)(4), PN (B)(4), LOT N003229, WAS MANUFACTURED TO THE NORIAN WORK ORDER (B)(4). THERE WERE NO MRRS, NCRS, OR COMPLAINT-RELATED ISSUES WITH THIS LOT. THE INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative · 1
INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED. REVIEW OF MANUFACTURING RECORDS HAS BEEN REQUESTED.
Description of Event or Problem · 1
DURING A PROCEDURE, THE NURSE OPENED THE FOLIO PACKAGE AND NOTICED A HOLE IN THE PACKAGE. THE PACKAGE WAS NOT USED. ANOTHER PACKAGE WAS OPENED FOR THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CHRONOS STRIP 100*25*3 | CHRONOS STRIP 100*25*3 | MQV | SYNTHES MONUMENT | N003229 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |