FDA Adverse Event
Malfunction
Summary report: N
TMINI MINIATURE ROBOTIC SYSTEM
MDR report key: 20092734
·
Received August 28, 2024
Report
- Report Number
- 3000719653-2024-00006
- Event Type
- Malfunction
- Date Received
- August 28, 2024
- Date of Event
- July 29, 2024
- Report Date
- August 28, 2024
- Manufacturer
- THINK SURGICAL, INC
- Product Code
- OLO
- UDI-DI
- M9461093430
- 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 SURGEON PLACED THE LATERAL PIN FURTHER INTO THE BONE TO ACCOUNT FOR THE PATIENT'S BONE QUALITY AND THE FINAL OUTCOME OF THE TOTAL KNEE IMPLANT WAS NOT CONSISTENT WITH THE PRE-OPERATIVE SURGICAL PLAN.
Description of Event or Problem · 0
IT WAS REPORTED THAT DURING SURGERY THE LATERAL PIN WAS PLACED FURTHER INTO THE BONE TO ACCOUNT FOR THE PATIENT'S BONE QUALITY. AS A RESULT IT APPEARED THAT IMPLANT PLACEMENT WAS NOT CONSISTENT WITH THE APPROVED SURGICAL PLAN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1464554 | TMINI MINIATURE ROBOTIC SYSTEM | ORTHOPEDIC SURGICAL ROBOT | OLO | THINK SURGICAL, INC | 109343 | M9461093430 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |