FDA Adverse Event
Summary report: N
NI
MDR report key: 2061211
·
Received April 5, 2011
Report
- Report Number
- 8030965-2011-00149
- Date Received
- April 5, 2011
- Date of Event
- January 18, 2011
- Report Date
- March 30, 2011
- Manufacturer
- SYNTHES (USA)
- Product Code
- DZI
- PMA / PMN Number
- NI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SYNTHES IS UNABLE TO PROVIDE THE MFR, PMA/510K NUMBER, AND/OR THE DATE OF MANUFACTURE AS NO PRODUCT WAS RETURNED AND NO PART/LOT NUMBER WAS PROVIDED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED AND NO PART/LOT NUMBER WAS PROVIDED.
Description of Event or Problem · 1
DURING A CLINICAL INVESTIGATION IT WAS REPORTED: A PT STATUS POST UNK (B)(4) DRILLABLE AND UNK PRODUCT RETURNED TO STUDY COMPLAINING OF PAIN SWELLING AND REDNESS (INFLAMMATORY REACTION). A CULTURE WAS TAKEN AND WAS NEGATIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NI | NI | DZI | SYNTHES (USA) | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention |