FDA Adverse Event
Injury
Summary report: N
X-STOP IPD SYSTEM
MDR report key: 1577890
·
Received December 31, 2009
Report
- Report Number
- 2953769-2009-00241
- Event Type
- Injury
- Date Received
- December 31, 2009
- Date of Event
- February 15, 2004
- Report Date
- September 30, 2008
- Manufacturer
- MEDTRONIC SPINE LLC
- Product Code
- NQO
- PMA / PMN Number
- P040001
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
REPORT SOURCE: ABSTRACT TITLED "TWO YEAR CLINICAL RESULTS OF X-STOP INTERSPINOUS DECOMPRESSION DEVICE IN THE MANAGEMENT OF SYMPTOMATIC LUMBAR CANAL STENOSIS" BY ANJALI NANDAKUMAR, MBBS, NATASHA ANNETTE CLARK, BSC, MBCHB, MRCS, NAVAL BILOLIKAR, ET AL. DEVICE NOT RETURNED, INTERNAL REVIEW OF LITERATURE, FOLLOW-UP WITH AUTHOR.
Description of Event or Problem · 1
IN AN ABSTRACT TITLED "TWO YEAR CLINICAL RESULTS OF X-STOP INTERSPINOUS DECOMPRESSION DEVICE IN THE MANAGEMENT OF SYMPTOMATIC LUMBAR CANAL STENOSIS", THE FOLLOWING EVENTS WERE REPORTED: TWO X-STOP EXPLANTS AFTER SLIPPAGE. ONE INTRA-OPERATIVE TEAR. TWO SLIPS WITH EPIDURAL INJECTION. NO ADDITIONAL INFORMATION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | X-STOP IPD SYSTEM | INTERSPINOUS PROCESS SPACER | NQO | MEDTRONIC SPINE LLC | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Other |