FDA Adverse Event
Malfunction
Summary report: N
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT: NAIL
MDR report key: 9241765
·
Received October 25, 2019
Report
- Report Number
- 3025141-2019-00404
- Event Type
- Malfunction
- Date Received
- October 25, 2019
- Report Date
- September 26, 2019
- Manufacturer
- ACUMED LLC
- Product Code
- LXH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL CASES ASSOCIATED WITH THIS ARTICLE: 3025141-2019-00405: CASE 2, 3025141-2019-00406: CASE 3, 3025141-2019-00407: CASE 4, 3025141-2019-00408: CASE 5, 3025141-2019-00409: CASE 6, 3025141-2019-00410: CASE 7.
Description of Event or Problem · 1
ARTICLE: THE RESULTS OF INTERNAL FIXATION OF THREE- AND FOUR-PART PROXIMAL HUMERAL FRACTURES WITH THE POLARUS NAIL, ADEDAPO, A.O., IKPEME, J.O.; INJURY: INTERNATIONAL JOURNAL OF THE CARE OF THE INJURED 32 (2001) 115-121. CASE 1: PATIENT INCAPACITATED BY SHOULDER PAIN 1 YEAR AFTER IMPLANTATION OF POLARUS NAIL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1037571 | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT: NAIL | LXH | ACUMED LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |