FDA Adverse Event
Malfunction
Summary report: N
TMINI MINIATURE ROBOTIC SYSTEM
MDR report key: 20092780
·
Received August 28, 2024
Report
- Report Number
- 3000719653-2024-00007
- Event Type
- Malfunction
- Date Received
- August 28, 2024
- Date of Event
- July 30, 2024
- Report Date
- August 28, 2024
- Manufacturer
- THINK SURGICAL, INC
- Product Code
- OLO
- UDI-DI
- M9461087570
- PMA / PMN Number
- K232802
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE DISTAL MEDIAL RESECTION WAS NOT CONSISTENT WITH THE PRE-OPERATIVE SURGICAL PLAN.
Description of Event or Problem · 0
IT WAS REPORTED THAT DURING SURGERY,THAT THE DISTAL MEDIAL RESECTION WAS LARGER THAN PLANNED. AS A RESULT IT APPERED THAT IMPLANT PLACEMENT WAS NOT CONSISTENT WITH THE APPROVED SURGICAL PLAN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1464566 | TMINI MINIATURE ROBOTIC SYSTEM | ORTHOPEDIC SURGICAL ROBOT | OLO | THINK SURGICAL, INC | 108757 | M9461087570 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |