FDA Adverse Event
Injury
Summary report: N
BIOPLATE TITANIUM FIXATION SYSTEM
MDR report key: 1990630
·
Received February 11, 2011
Report
- Report Number
- 2029447-2011-00001
- Event Type
- Injury
- Date Received
- February 11, 2011
- Date of Event
- February 8, 2011
- Report Date
- February 9, 2011
- Manufacturer
- BIOPLATE
- Product Code
- JEY
- PMA / PMN Number
- K082757
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE SOURCE OF THE REPORT IS FROM A SALES REP WHO WAS NOT PRESENT AT THE SURGERY. INITIAL F/U DISCUSSIONS REVEAL THE PT IS DOING WELL. THE HOSP HAS STATED THEY DO NOT INTEND TO FILE AN INCIDENT REPORT. ACCORDING TO THE HOSP STAFF, IT IS UNCLEAR THAT AN INCIDENT ACTUALLY OCCURRED AS MENTIONED. WE ARE CURRENTLY CONDUCTING A DETAILED INVESTIGATION. ADDITIONAL CATALOG#: 81-5751.
Description of Event or Problem · 1
UPON DRIVING IN THE SCREW, BLADE SLIPPED OUT OF THE SCREW INTERFACE AND THE BLADE PLUNGED INTO THE SINUS. PT LOST EXCESSIVE BLOOD. NEUROSURGEON HAD TO REPAIR SINUS AND MINIMIZE BLOOD LOSS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOPLATE TITANIUM FIXATION SYSTEM | BONE FIXATION PLATES AND BONE SCREWS | JEY | BIOPLATE | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |