FDA Adverse Event
Malfunction
Summary report: N
2520274-2013-03447
MDR report key: 3172948
·
Received June 17, 2013
Report
- Report Number
- 2520274-2013-03447
- Event Type
- Malfunction
- Date Received
- June 17, 2013
- Report Date
- May 20, 2013
- Manufacturer
- SYNTHES USA
- Product Code
- MNI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.
Description of Event or Problem · 1
DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT UNDERWENT IMPLANT SURGERY PREVIOUSLY IN INDIA ON AN UNKNOWN DATE. ON AN UNKNOWN DATE, THE PATIENT BEGAN EXPERIENCING BACK PAIN. PATIENT WAS SEEKING A MEDICAL INSTITUTION IN (B)(6) WITH EXPERIENCE WITH SYNTHES PRODUCTS. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR THE UNKNOWN SPINAL IMPLANT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 272965 | MNI | SYNTHES USA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |