FDA Adverse Event
Malfunction
Summary report: N
ZYSTON CURVE SPACER SYSTEM AND INSTRUMENTS
MDR report key: 2266269
·
Received September 27, 2011
Report
- Report Number
- 2242816-2011-00116
- Event Type
- Malfunction
- Date Received
- September 27, 2011
- Date of Event
- September 8, 2011
- Report Date
- September 8, 2011
- Manufacturer
- EBI, LLC
- Product Code
- MAX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS IS 2 OF 4 MDRS RELATING TO THE SAME REPORTED EVENT. PLEASE ALSO SEE MDR NUMBER: 2242816-2011-00115, 2242816-2011-00117, 2242816-2011-00118.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHILE PERFORMING A 2-LEVEL TLIF, THE INSERTERS FRACTURED AT THE DISTAL TIPS AND THE CAGES HAD TO BE EXPLANTED. PATIENT OUTCOME: NO ADVERSE EFFECT REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZYSTON CURVE SPACER SYSTEM AND INSTRUMENTS | CURVE VARIABLE INSERTER SHAFT | MAX | EBI, LLC | PT15C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |