FDA Adverse Event
Injury
Summary report: N
SUP DIST CLAV LK PL L 109MM
MDR report key: 4874776
·
Received June 29, 2015
Report
- Report Number
- 1020279-2015-00422
- Event Type
- Injury
- Date Received
- June 29, 2015
- Date of Event
- July 13, 2015
- Report Date
- December 26, 2017
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- HRS
- PMA / PMN Number
- K061352
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
.
Additional Manufacturer Narrative · 1
(B)(4). NO PRODUCT WAS RETURNED, HENCE VISUAL OR DIMENSIONAL INSPECTION COULD NOT BE COMPLETED. NO LOT NUMBER WAS PROVIDED; HENCE DHR COULD NOT BE COMPLETED. IF MORE INFORMATION IS RECEIVED, THIS INVESTIGATION WILL BE REOPENED.
Additional Manufacturer Narrative · 1
CORRECTIONS BASED ON NEW INFORMATION RECEIVED.
Additional Manufacturer Narrative · 1
PLEASE SEE THE ATTACHED FILE FOR THE RESULTS OF OUR INVESTIGATION. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE CLAVICLE PLATE BROKE. THE REVISION SCHEDULED FOR (B)(6) 2015 WAS CANCELLED AND HAS NOT BEEN RESCHEDULED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO REMOVE BROKEN CLAVICLE PLATE.
Description of Event or Problem · 1
07/13/2015 - UPDATED INFORMATION - IT WAS REPORTED THAT A REVISION WAS PERFORMED TO REMOVE THE BROKEN CLAVICLE PLATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 420141 | SUP DIST CLAV LK PL L 109MM | BONE PLATES AND BONE SCREWS | HRS | SMITH & NEPHEW, INC. | 14JM17652 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Hospitalization| O| R |