FDA Adverse Event
Injury
Summary report: N
6.0MM TI PANGEA POLYAXIAL SCREW
MDR report key: 2032606
·
Received March 23, 2011
Report
- Report Number
- 8030965-2011-00091
- Event Type
- Injury
- Date Received
- March 23, 2011
- Report Date
- March 7, 2010
- Manufacturer
- SYNTHES GMBH
- Product Code
- NKB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS ONGOING, NO CONCLUSION CAN BE DRAWN AT THIS TIME.
Description of Event or Problem · 1
DEVICE REPORT RECEIVED FROM HOSPITAL (B)(6), INDICATES THAT THREE PANGEA HEADS POPPED OFF THE BONE SCREWS INSIDE THE PATIENT. THE PATIENT DID NOT SUFFER ANY TRAUMA THAT COULD HAVE LED TO THIS SITUATION. THE HEADS WERE REMOVED FROM THE PATIENT. THIS REPORT IS 3 OF 3 FOR THE SAME EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 6.0MM TI PANGEA POLYAXIAL SCREW | 6.0MM TI PANGEA POLYAXIAL SCREW | NKB | SYNTHES GMBH | NA | 6213004 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention | SCREWS| LOCKING CAPS |