MalfunctionLXI
INCORE LAPIDUS TARGETING GUIDE ASSEMBLY RIGHT, REUSABLE
Received Aug 10, 2020 · Event occurred Jul 10, 2020
Report 3009540749-2020-00022 · MDR key 10384553
Device
Product problems
- No Apparent Adverse Event
- No Apparent Adverse Event
Patient
54 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
IF ADDITIONAL INFORMATION IS RECEIVED WHICH CHANGES THE OUTCOME OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED DURING A SURGERY ON (B)(6) 2020 THE INCORE LAPIDUS TARGETING GUIDE ASSEMBLY RIGHT FROZE. THE SURGERY WAS DELAYED FOR ABOUT AN HOUR. SURGERY WAS COMPLETED USING ANOTHER SYSTEM. PATIENT OUTCOME WAS REPORTED AS GOOD AND THERE WERE NO PATIENT COMPLICATIONS.