FDA Adverse Event
Injury
Summary report: N
DXTEND MBLOC HUM EPI 1 D12 STD
MDR report key: 1033570
·
Received April 23, 2008
Report
- Report Number
- 1818910-2008-01179
- Event Type
- Injury
- Date Received
- April 23, 2008
- Date of Event
- March 24, 2008
- Report Date
- March 24, 2008
- Manufacturer
- DEPUY FRANCE S.A.
- Product Code
- HSD
- PMA / PMN Number
- K062250
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.
Description of Event or Problem · 1
DURING SURGERY, THE POLY WOULD NOT SEAT INTO THE STEM CAUSING A 30 MIN DELAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DXTEND MBLOC HUM EPI 1 D12 STD | 87HSD; 87KWS | HSD | DEPUY FRANCE S.A. | NA | 2484953 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |