FDA Adverse Event
Injury
Summary report: N
X-STOP IPD SYSTEM
MDR report key: 931610
·
Received October 24, 2007
Report
- Report Number
- 2953769-2007-00036
- Event Type
- Injury
- Date Received
- October 24, 2007
- Date of Event
- September 12, 2007
- Report Date
- September 24, 2007
- Manufacturer
- KYPHON, INC.
- Product Code
- NQO
- PMA / PMN Number
- P040001
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE #2: CATALOG #1-2214, LOT #2052841, EXPIRATION DATE: 01/2009.: DEVICE MFR DATE: 1/2007. METHOD: FOLLOW UP CONVERSATION WITH TREATING PHYSICIAN. RESULTS: NO CONCLUSION CAN BE DRAWN AT THIS TIME.
Description of Event or Problem · 1
PT UNDERWENT AN X-STOP PROCEDURE AT LEVELS L3/L4 AND L4/L5. IT WAS REPORTED THAT APPROXIMATELY 12 DAYS FOLLOWING THE PROCEDURE, BOTH IMPLANTS WERE REMOVED DUE TO AN INFECTION OF UNK ORIGIN, AT THE TREATED LEVELS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | X-STOP IPD SYSTEM | INTERSPINOUS PROCESS PROSTHESIS | NQO | KYPHON, INC. | NA | 2052784 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Required Intervention |