FDA Adverse Event
Injury
Summary report: N
PTN
MDR report key: 1517094
·
Received October 28, 2009
Report
- Report Number
- 2242816-2009-00103
- Event Type
- Injury
- Date Received
- October 28, 2009
- Date of Event
- June 1, 2009
- Report Date
- October 15, 2009
- Manufacturer
- EBI, LLC
- Product Code
- HSB
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PO
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL PARTS INVOLVED IN EVENT:PART NO. LOT NO. MFG. DATE.29258 302600 05/13/0833-345424 216270 11/03/05DHRS FOR THE PARTS WERE REVIEWED, AND NO ANOMALIES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS.
Additional Manufacturer Narrative · 1
NEW INFORMATION INDICATES DEVICES WERE NOT EXPLANTED.
Description of Event or Problem · 1
X-RAY DEMONSTRATED BROKEN NAIL. IMPLANTS REMOVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "DURING THE TKA, THE SURGEON COULD NOT LOCK THE INSERT ONTO THE TIBIAL BASE PLATE. THEREFORE, HE USED A SPARE INSERT INSTEAD OF IT."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PTN | TROCHANTERIC NAIL | HSB | EBI, LLC | 787280 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Required Intervention |