FDA Adverse Event
Malfunction
Summary report: N
TIBIAL CHECKPOINT STERILE
MDR report key: 24380548
·
Received February 18, 2026
Report
- Report Number
- 3005985723-2026-00081
- Event Type
- Malfunction
- Date Received
- February 18, 2026
- Date of Event
- January 26, 2026
- Report Date
- February 18, 2026
- Manufacturer
- MAKO SURGICAL CORP.
- Product Code
- OLO
- UDI-DI
- 00848486001353
- PMA / PMN Number
- K172219
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
THE FOLLOWING INFORMATION WAS PROVIDED: TIBIAL CHECKPOINT (CODE 111651) SNAPPED AT THE TIP WHILST BEING REMOVED FROM PATIENT AT THE END OF A LEFT MAKO PARTIAL KNEE REPLACEMENT. PATIENT AWAITING XR TO SEE IF TIP OF CHECKPOINT IS STILL IN SITU. NOTE THIS X-RAY WOULD HAVE BEEN STANDARD POST OP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 449460 | TIBIAL CHECKPOINT STERILE | ORTHOPEDIC STEREOTAXIC INSTRUMENT | OLO | MAKO SURGICAL CORP. | UNKNOWN | 00848486001353 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Female |