NAIL, FIXATION, BONE
Report
- Report Number
- 2520274-2016-13974
- Event Type
- Injury
- Date Received
- August 9, 2016
- Report Date
- July 28, 2016
- Manufacturer
- SYNTHES USA
- Product Code
- JDS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. LITERATURE CITATION:KEENER, JAY D. M.D. AND DAHNERS, LAURENCE E. M.D. "PERCUTANEOUS PINNING OF DISPLACED MIDSHAFT CLAVICLE FRACTURES": TECHNIQUES IN SHOULDER AND ELBOW SURGERY 7(4): 175-181, 2006. UNITED STATES ARTICLE. THIS REPORT IS FOR UNKNOWN NAIL, UNKNOWN QUANTITY, UNKNOWN LOT. UDI: UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED.
THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE, KEENER, JAY D. M.D. AND DAHNERS, LAURENCE E. M.D. "PERCUTANEOUS PINNING OF DISPLACED MIDSHAFT CLAVICLE FRACTURES": TECHNIQUES IN SHOULDER AND ELBOW SURGERY 7(4): 175-181, 2006. UNITED STATES ARTICLE IN THIS ARTICLE, SURGICAL TECHNIQUE FOR ANTEROGRADE PINNING OF DISPLACED MIDSHAFT CLAVICLE FRACTURES WAS DISCUSSED. THE STUDY INCLUDED TWENTY FOUR (24) PATIENTS WITH DISPLACED CLAVICLE FRACTURES (OVER 3 YEARS) THAT WERE STABILIZED WITH A FLEXIBLE TITANIUM NAIL. THREE (3) PATIENTS WERE LOST TO FOLLOW UP. THE FOLLOWING ADVERSE EVENTS/COMPLICATIONS WERE NOTED. DELAYED UNION. HARDWARE IRRITATION AT IMPLANTATION SITE WITH ELECTIVE HARDWARE REMOVAL. THIS REPORT IS FOR AN UNKNOWN TITANIUM ELASTIC NAIL (TEN).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 509740 | NAIL, FIXATION, BONE | JDS | SYNTHES USA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |