FDA Adverse Event
Injury
Summary report: N
6.0MM TI HARD ROD 300MM
MDR report key: 2994656
·
Received March 8, 2013
Report
- Report Number
- 2530088-2013-00289
- Event Type
- Injury
- Date Received
- March 8, 2013
- Report Date
- October 3, 2012
- Manufacturer
- SYNTHES BRANDYWINE
- Product Code
- MNH
- PMA / PMN Number
- K943725
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: ADDITIONAL CODES: MNI, KWP. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER.
Description of Event or Problem · 1
PATIENT WAS IMPLANTED WITH TWO RODS ON (B)(6) 2010. REPORTEDLY THE RODS BROKE POST OPERATIVE. REMOVAL OF THE RODS IS UNKNOWN. THIS REPORT IS #2 OF 2 FOR THE SAME EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 99989 | 6.0MM TI HARD ROD 300MM | MNH | SYNTHES BRANDYWINE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Required Intervention |