FDA Adverse Event
Injury
Summary report: N
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT: NAIL
MDR report key: 9241772
·
Received October 25, 2019
Report
- Report Number
- 3025141-2019-00408
- Event Type
- Injury
- Date Received
- October 25, 2019
- Report Date
- September 26, 2019
- Manufacturer
- ACUMED LLC
- Product Code
- LXH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL CASES ASSOCIATED WITH THIS ARTICLE: 3025141-2019-00404: CASE 1, 3025141-2019-00405: CASE 2, 3025141-2019-00406: CASE 3, 3025141-2019-00407: CASE 4, 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 5: A POLARUS NAIL WAS IMPLANTED. PATIENT EXPERIENCED PROXIMAL SCREW LOOSENING AND EXTRUSION THAT CAUSED PAIN; THE SCREWS WERE REMOVED IN A REVISION SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1031318 | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT: NAIL | LXH | ACUMED LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |