FDA Adverse Event
Injury
Summary report: N
LOCKING CORTICAL/CANCELLOUS SCREW
MDR report key: 3335287
·
Received September 9, 2013
Report
- Report Number
- 3025141-2013-00098
- Event Type
- Injury
- Date Received
- September 9, 2013
- Date of Event
- July 14, 2011
- Report Date
- September 27, 2012
- Manufacturer
- ACUMED LLC
- Product Code
- HRS
- PMA / PMN Number
- K012655
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL MDRS ASSOCIATED WITH THIS EVENT: MDR# : PART DESCRIPTION: 3025141-2013-00092, 8-HOLE PRECONTOURED CLAVICLE PLATE, 3025141-2013-00093, LOCKING CORTICAL/CANCELLOUS SCREW, 3025141-2013-00094, LOCKING CORTICAL/CANCELLOUS SCREW, 3025141-2013-00095, LOCKING CORTICAL/CANCELLOUS SCREW, 3025141-2013-00096, LOCKING CORTICAL/CANCELLOUS SCREW, 3025141-2013-00097, LOCKING CORTICAL/CANCELLOUS SCREW.
Description of Event or Problem · 1
TWO SCREWS ASSOCIATED WITH AN 8-HOLE PRE-CONTOURED CLAVICLE PLATE LOOSENED REDUCING THE EFFECTIVENESS OF THE IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 445930 | LOCKING CORTICAL/CANCELLOUS SCREW | HRS | ACUMED LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention |