FDA Adverse Event
Injury
Summary report: N
PLATE, FIXATION, BONE
MDR report key: 9489915
·
Received December 18, 2019
Report
- Report Number
- 3025141-2019-00614
- 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: 3025141-2019-00612: CASE 1, 3025141-2019-00613: CASE 2.
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 3: PATIENT'S BROKEN CLAVICLE WAS TREATED BY IMPLANTING AN ACUMED LOCKING CLAVICLE PLATE. THE PATIENT FELL POST OP AND SOME OF THE SCREWS WERE PULLED OUT. THE PLATE AND SCREWS WERE EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1285135 | PLATE, FIXATION, BONE | HRS | ACUMED LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |