FDA Adverse Event
Injury
Summary report: N
DSS STABILIZATION SYSTEM- SLOTTED.
MDR report key: 1591234
·
Received February 1, 2010
Report
- Report Number
- 3005725110-2010-00002
- Event Type
- Injury
- Date Received
- February 1, 2010
- Date of Event
- January 5, 2010
- Report Date
- January 27, 2010
- Manufacturer
- PARADIGM SPINE GMBH
- Product Code
- NQP
- PMA / PMN Number
- K080963
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
PLEASE NOTE THAT THE REGISTRATION NUMBER IS FOR THE (B) (4) OFFICE. OUR (B) (4) OFFICE IS BEING REGISTERED AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT BOTH SLOTTED COUPLERS OF LEVEL L3- L4 FRACTURED. THE SURGEON INDICATED THAT A REVISION SURGERY WILL BE PERFORMED TO REPLACE THE CONCERNED IMPLANTS. PLEASE NOTE THAT THIS IS ONE INCIDENT WITH ONE PATIENT WHERE TWO IMPLANTS ARE INVOLVED. THE CORRESPONDING MFR REPORT IS 3005725110-2010-00001.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DSS STABILIZATION SYSTEM- SLOTTED. | SLOTTED COUPLER | NQP | PARADIGM SPINE GMBH | DPI35035 | 2008503236 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |