FDA Adverse Event
Malfunction
Summary report: N
BALLISTA INSTRUMENTS
MDR report key: 1981558
·
Received February 8, 2011
Report
- Report Number
- 2242816-2011-00008
- Event Type
- Malfunction
- Date Received
- February 8, 2011
- Date of Event
- January 17, 2011
- Report Date
- January 17, 2011
- Manufacturer
- EBI, LLC
- Product Code
- LXH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL PIECE INVOLVED IN EVENT:PART NO. LOT NO. MFG. DATE2000-6349 P202160 03/11/2010
Description of Event or Problem · 1
IT WAS REPORTED THAT, DURING A CASE, A ROD INSERTER FRACTURED RESULTING IN A DELAY OF AT LEAST THIRTY MINUTES. FRACTURED PIECE WAS REMOVED. PATIENT OUTCOME: NO ADVERSE EFFECT REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BALLISTA INSTRUMENTS | ROD INSERTER | LXH | EBI, LLC | P078856 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |