FDA Adverse Event
Injury
Summary report: N
ERISMA LP
MDR report key: 9291175
·
Received November 7, 2019
Report
- Report Number
- 3008992889-2019-00002
- Event Type
- Injury
- Date Received
- November 7, 2019
- Date of Event
- September 20, 2019
- Report Date
- November 7, 2019
- Manufacturer
- CLARIANCE SAS
- Product Code
- NKB
- UDI-DI
- 03700780625154
- PMA / PMN Number
- K153326
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
FOR THIS ADVERSE EVENT, AS THE INCRIMINATED DEVICE HAS NOT BEEN RECEIVED YET, CLARIANCE (B)(4) IS UNABLE TO DO ANY ANALYSIS FOR THE MOMENT. NO ADDITIONAL INFORMATION ARE AVAILABLE. CLARIANCE WILL GO FORWARD ON THE INVESTIGATION WHEN THE INSTRUMENT IS RECEIVED.
Description of Event or Problem · 1
SCREWDRIVER TIP BROKE OFF INSIDE THE SCREW HEAD. SHEARED OFF CLEANLY SO SURGEON LEFT THE SHEARED FRAGMENT IN PLACE AND LOCKED ROD DOWN OVERTOP OF IT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1086475 | ERISMA LP | SCREWDRIVER | NKB | CLARIANCE SAS | 18911039 | H224X | 03700780625154 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |