FDA Adverse Event
Malfunction
Summary report: N
X-STOP IPD SYSTEM
MDR report key: 1694454
·
Received May 12, 2010
Report
- Report Number
- 2953769-2010-00192
- Event Type
- Malfunction
- Date Received
- May 12, 2010
- Date of Event
- April 19, 2010
- Report Date
- April 16, 2010
- Manufacturer
- MEDTRONIC SPINE LLC.
- Product Code
- NQO
- PMA / PMN Number
- P040001
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADD'L LOT: # 2052743. (B)(4). DEVICE WAS NOT RETURNED; FOLLOWED UP WITH COMPANY REP.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PT UNDERWENT A SUCCESSFUL X-STOP PROCEDURE AT LEVELS L2/L3 AND L3/L4. REPORTEDLY, BOTH DEVICES WERE REMOVED DUE TO RECURRENCE OF SYMPTOMS. A LAMINECTOMY WITH A POSTERIOR FUSION WAS PERFORMED. IT WAS NOTED THAT THE PT HAD AN EXCELLENT RESPONSE TO THE INITIAL SURGERY. NO ADDITIONAL INFO 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. | NA | 2052841 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |