FDA Adverse Event
Injury
Summary report: N
HPS 1.6MM 3 X 8 T PLATE, LOCKING
MDR report key: 4570267
·
Received March 2, 2015
Report
- Report Number
- 2027754-2015-00003
- Event Type
- Injury
- Date Received
- March 2, 2015
- Date of Event
- February 17, 2015
- Report Date
- March 2, 2015
- Manufacturer
- OSTEOMED
- Product Code
- HRS
- PMA / PMN Number
- K090522
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ID
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
ON (B)(6) 2015, OSTEOMED RECEIVED NOTIFICATION OF AN INCIDENT CONCERNING THE OSTEOMED 1.6MM 3 X 8 T PLATE, LOCKING (PART # 333-1606). THE INCIDENT WAS REPORTED BY ONE OF OUR INTERNATIONAL DISTRIBUTORS - PT PRO-HEALTH INTERNATIONAL. PER THE DISTRIBUTOR, ONE OF THEIR ORTHOPAEDIC CUSTOMERS IMPLANTED THE PLATE ON (B)(6) 2015. FOUR (4) WEEKS FOLLOWING THE SURGERY, THE PLATE BROKE INSIDE THE PATIENT. PER THE DISTRIBUTOR, ONCE THE PLATE HAS BEEN EXPLANTED, IT WILL BE SENT TO OSTEOMED FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 144218 | HPS 1.6MM 3 X 8 T PLATE, LOCKING | 1.6MM 3 X 8 T PLATE, LOCKING | HRS | OSTEOMED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR | Hospitalization |