FDA Adverse Event
Malfunction
Summary report: N
ACU-LOC® 2 VDR PROX PLT, STD LONG, L
MDR report key: 8883610
·
Received August 12, 2019
Report
- Report Number
- 3025141-2019-00345
- Event Type
- Malfunction
- Date Received
- August 12, 2019
- Date of Event
- July 16, 2019
- Report Date
- July 17, 2019
- Manufacturer
- ACUMED LLC
- Product Code
- HRS
- PMA / PMN Number
- K102998
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL MDRS ASSOCIATED WITH THIS EVENT: 3025141-2019-00344: SCREW.
Description of Event or Problem · 1
WHILE IMPLANTING AN ACULOC 2 PLATE, A LOCKING SCREW STRIPPED AND WAS SPINNING IN THE PLATE. IT COULD NOT BE REMOVED AND WAS LEFT IMPLANTED. THERE WAS A 15 MINUTE DELAY IN SURGERY AS A RESULT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 677457 | ACU-LOC® 2 VDR PROX PLT, STD LONG, L | PLATE, FIXATION, BONE | HRS | ACUMED LLC | 70-0372 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 DA |