FDA Adverse Event
Injury
Summary report: N
PLATE, FIXATION, BONE
MDR report key: 9483471
·
Received December 17, 2019
Report
- Report Number
- 3025141-2019-00607
- Event Type
- Injury
- Date Received
- December 17, 2019
- Report Date
- November 25, 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: 3025141-2019-00606: CASE 1.
Description of Event or Problem · 1
ARTICLE: THE CLAVICLE TRIAL - A MULTICENTER RANDOMIZED CONTROLLED TRIAL COMPARING OPERATIVE WITH NONOPERATIVE TREATMENT OF DISPLACED MIDSHAFT CLAVICLE FRACTURES; AHRENS, PHILIP M., FRCS; GARLICK, NICHOLAS I., FRCS; BARBER, JULIE, PHD; TIMS, EMILY M., MSC AND THE CLAVICLE COLLABORATIVE; J BONE SURG AM. 2017; 99:1345-54. CASE 2: PATIENT EXPERIENCED REMOVAL OF THE PLATE FOLLOWING IMPLANTATION OF AN ACUMED CLAVICLE PLATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1272268 | PLATE, FIXATION, BONE | HRS | ACUMED LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |