FDA Adverse Event
Death
Summary report: N
NI
MDR report key: 1407467
·
Received June 23, 2009
Report
- Report Number
- 2520274-2009-00117
- Event Type
- Death
- Date Received
- June 23, 2009
- Report Date
- May 26, 2009
- Manufacturer
- SYNTHES (USA)
- Product Code
- MQN
- PMA / PMN Number
- K040083
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PT REPORTEDLY DIED APPROXIMATELY 30 HOURS POST OPERATIVE. MANUFACTURER SITE AND MANUFACTURE DATE CANNOT BE DETERMINED WITHOUT A LOT NUMBER. INVESTIGATION COULD NOT BE CONCLUDED, NO CONCLUSION COULD BE DRAWN. 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
AN EXTERNAL MIDFACE DISTRACTOR WAS IMPLANTED ON A PT. APPROXIMATELY 30 HOURS POST-OPERATIVE, THE PT DIED. THE NEUROSURGEON INDICATED HE DOES NOT BELIEVE THAT THE DEATH IS DEVICE RELATED BECAUSE IT DID NOT OCCUR IMMEDIATELY POST-OPERATIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NI | EXTERNAL MIDFACE DISTRACTOR | MQN | SYNTHES (USA) | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Death |