FDA Adverse Event
Injury
Summary report: N
PLATE, FIXATION, BONE
MDR report key: 9527108
·
Received December 27, 2019
Report
- Report Number
- 3025141-2019-00697
- Event Type
- Injury
- Date Received
- December 27, 2019
- Report Date
- December 23, 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: 3025141-2019-00695: CASE 1, 3025141-2019-00696: CASE 2.
Description of Event or Problem · 1
ARTICLE: DISPLACED MIDSHAFT CLAVICLE FRACTURE IN ATHLETES - SHOULD WE OPERATE?; DE SOUZA, NEYDSON ANDRE SOLPOSTO MARQUES; BELANGERO, PAULO SANTORO; DE FIGUEIREDO, EDUARDO ANTONIO; POCHINI, ALBERTO DE CASTO; ANDREOLI, CARLOS VICENTE; EJNISMAN, BENNO; REV BRAS ORTOP, 2018; 53(2): 171-175. CASE 3: PATIENT'S BROKEN CLAVICLE WAS TREATED BY IMPLANTING AN ACUMED MIDSHAFT CLAVICLE PLATE. PATIENT EXPERIENCED THROMBOSIS OF THE SUBCLAVIAN VEIN WHICH RESPONDED TO CONSERVATIVE TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1319803 | PLATE, FIXATION, BONE | HRS | ACUMED LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |