FDA Adverse Event
Injury
Summary report: N
PLATE, FIXATION, BONE
MDR report key: 9482196
·
Received December 17, 2019
Report
- Report Number
- 3025141-2019-00599
- Event Type
- Injury
- Date Received
- December 17, 2019
- Report Date
- November 25, 2019
- Manufacturer
- ACUMEDLLC
- 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: 3025141-2019-00598: CASE 1, 3025141-2019-00600: CASE 3, 3025141-2019-00601: CASE 4, 3025141-2019-00602: CASE 5, 3025141-2019-00603: CASE 6, 3025141-2019-00604: CASE 7, 3025141-2019-00605: CASE 8.
Description of Event or Problem · 1
ARTICLE: DISPLACED MID-SHAFT CLAVICULAR FRACTURES: SURGICAL TREATMENT WITH A PRE-CONTOURED ANGULAR STABILITY PLATE; CAMPOCHIARO, GABRIELE; TSATSIS, CHRISTOS; GAZZOTTI, GABRIELE; REBUZZI, MANUELA AND CATANI, FABIO; MUSCULOSKELET SURG (2012) 96 (SUPPL 1):S21-S26. CASE 2: PATIENT WAS IMPLANTED WITH AN ACUMED CLAVICLE PLATE; AFTER FRACTURE CONSOLIDATION, THE PLATE WAS REMOVED FOR INTOLERANCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1272406 | PLATE, FIXATION, BONE | HRS | ACUMEDLLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |