FDA Adverse Event
Injury
Summary report: N
PLATE, FIXATION, BONE
MDR report key: 9489899
·
Received December 18, 2019
Report
- Report Number
- 3025141-2019-00612
- Event Type
- Injury
- Date Received
- December 18, 2019
- Report Date
- November 27, 2019
- Manufacturer
- ACUMED LLC
- Product Code
- HRS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL MDRS ASSOCIATED WITH THIS ARTICLE: 3025141-2019-00613: CASE 2, 3025141-2019-00614: CASE 3.
Description of Event or Problem · 1
ARTICLE: THE EFFECTIVENESS OF A FLEXIBLE LOCKED INTRAMEDULLARY NAIL AND AN ANATOMICALLY CONTOURED LOCKED PLATE TO TREAT CLAVICULAR SHAFT FRACTURES: A 1-YEAR RANDOMIZED CONTROL TRIAL; KING, PAUL R. FCSA; IKRAM, AJMAL, FCSA; EKEN, MAAIKE M. PHD, LAMBREETS, ROBERT P. PHD, FECSS; J BONE JOINT SURG AM. 2019:101:628-34. CASE 1: PATIENT'S BROKEN CLAVICLE WAS TREATED BY IMPLANTING AN ACUMED LOCKING CLAVICLE PLATE. PATIENT EXPERIENCED A SUPERFICIAL WOUND INFECTION AND WAS TREATED WITH ANTIBIOTICS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1284901 | PLATE, FIXATION, BONE | HRS | ACUMED LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |