FDA Adverse Event
Injury
Summary report: N
PLATE, FIXATION, BONE
MDR report key: 9495883
·
Received December 19, 2019
Report
- Report Number
- 3025141-2019-00626
- Event Type
- Injury
- Date Received
- December 19, 2019
- Report Date
- December 6, 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: 3025141-2019-00627: CASE 2, 3025141-2019-00628: CASE 3, 3025141-2019-00629: CASE 4.
Description of Event or Problem · 1
ARTICLE: LOCKED ANATOMIC PLATE FIXATION IN DISPLACED CLAVICULAR FRACTURES; OZLER, TURHAN; GUVEN, MELIH; KOCADAL, ABDURRAHMAN ONUR; ULUCAY, CAGATAY; BEYZADEOGLU, TAHSIN; AND ALTINITAS, FAIK; ACTA ORTHOP TRAUMATOL TURC 2012; 46(4):237-242. CASE 1: PATIENT'S BROKEN CLAVICLE WAS TREATED BY IMPLANTING AN ACUMED LOCKING CLAVICLE PLATE. PATIENT EXPERIENCED IMPLANT IRRITATION; IMPLANTS REMOVED AFTER HEALING AT 4 MONTHS POST OP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1292427 | PLATE, FIXATION, BONE | HRS | ACUMED LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |