FDA Adverse Event
Injury
Summary report: N
HYDROSET ORTHO
MDR report key: 1983909
·
Received February 4, 2011
Report
- Report Number
- 8010177-2011-00038
- Event Type
- Injury
- Date Received
- February 4, 2011
- Date of Event
- March 9, 2010
- Report Date
- January 13, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- GXP
- PMA / PMN Number
- K060763
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED FOR EVALUATION. INTERNAL INVESTIGATION IN PROCESS.
Description of Event or Problem · 1
IT WAS REPORTED THAT "IT WAS REPORTED THROUGH THE ATTORNEY FOR THE PT, AS A RESULT OF A LEGAL CLAIM, THAT ALLEGEDLY 'ON (B)(6) 2007, THE PT UNDERWENT FRONTAL SINUS RECONSTRUCTION. IT WAS FURTHER ALLEGED THAT, 'DURING THE SURGERY STRYKER HYDROSET WAS INJECTED. SHORTLY AFTER THE SURGERY, THE PT BEGAN TO EXPERIENCE POST-OPERATIVE SWELLING OF THE FOREHEAD REGION.' IT WAS FURTHER ALLEGED THAT, 'ON (B)(6) 2010, DR (B)(6) REMOVED THE REMAINS OF THE INJECTED HYDROSET."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HYDROSET ORTHO | IMPLANT | GXP | STRYKER ORTHOPAEDICS LIMERICK | NA | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |