FDA Adverse Event
Malfunction
Summary report: N
2520274-2013-01440
MDR report key: 3003093
·
Received March 13, 2013
Report
- Report Number
- 2520274-2013-01440
- Event Type
- Malfunction
- Date Received
- March 13, 2013
- Report Date
- February 19, 2013
- Manufacturer
- SYNTHES USA
- Product Code
- MNI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.
Description of Event or Problem · 1
PATIENT PARTICIPATED IN A STUDY FOR THE PRODUCT CHRONOS STRIP ON (B)(6) 2011. PATIENT WAS IMPLANTED WITH 100 MM X 25 MM X 3 MM CHRONOS STRIP USING 8CC BONE MARROW ASPIRATE AND 60CC LOCAL BONE. PATIENT WAS ALSO IMPLANTED WITH MATRIX IMPLANT AT L3-L4 AND L4-L5. POST OPERATIVELY, ON (B)(6) 2012, PATIENT PRESENTED WITH WORSENING LOWER BACK PAIN, BILATERAL BUTTOCKS, BILATERAL LEGS, BILATERAL NUMBNESS IN FEET, AND PAIN IN SACRUM. THIS REPORT IS FOR A LOCKING CAP. THIS IS 12 OF 15 REPORTS FOR THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 105204 | MNI | SYNTHES USA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |