FDA Adverse Event
Malfunction
Summary report: N
2520274-2013-03596
MDR report key: 3180573
·
Received June 20, 2013
Report
- Report Number
- 2520274-2013-03596
- Event Type
- Malfunction
- Date Received
- June 20, 2013
- Date of Event
- May 24, 2013
- Report Date
- May 23, 2013
- Manufacturer
- SYNTHES USA
- Product Code
- HTO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER. THIS DEVICE WAS USED FOR TREATMENT.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: A PROFESSOR REPORTED THAT AFTER AN UNSPECIFIED SURGERY USING THE RIA SYSTEM, THE PATIENT IS COMPLAINING OF A LOT OF PAIN. A BONE SCAN REVEALED SOME WHITE SPOTS THOUGHT TO BE OSTEONECROSIS BY THE PROFESSOR. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 281539 | HTO | SYNTHES USA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |