ERISMA-LP MIS
Received Mar 4, 2020 · Event occurred Apr 23, 2019
Report 3009962553-2019-00004 · MDR key 9786270
Device
Generic name
6.5mm X 40mm Cannulated Polyaxial Screw
Manufacturer
Clariance SasModel number
13016540Catalog number
13016540
Lot number
GA17C
Product problems
- Positioning Failure
- Positioning Failure
Patient
82 YR
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE SCREW WAS RETURNED TO THE MANUFACTURER, HOWEVER, THE SET SCREW WAS NOT RETURNED. AS A CONSEQUENCE, NO ANALYSIS WAS ABLE TO BE PERFORMED. 12/20/2019 - THE SCREW WAS RETURNED TO THE MANUFACTURER, HOWEVER, THE SET SCREW WAS NOT RETURNED. AS A CONSEQUENCE, NO ANALYSIS WAS ABLE TO BE PERFORMED.
Description of Event or Problem
THE SET SCREW WOULD NOT START AND ENGAGE THE THREAD OF THE HEAD OF THE ERISMA-LP MIS POLYAXIAL SCREW. THERE WAS A DELAY OF 30 MINUTES ASSOCIATED WITH REMOVING THE SCREW AND REPLACING IT WITH AN ALTERNATIVE PEDICLE SCREW. HOWEVER, NO PATIENT HARM WAS REPORTED AND THE SURGERY COMPLETED WITHOUT FURTHER INCIDENT.
Additional Manufacturer Narrative
THE SCREW WAS RETURNED TO THE MANUFACTURER, HOWEVER, THE SET SCREW WAS NOT RETURNED. AS A CONSEQUENCE, NO ANALYSIS WAS ABLE TO BE PERFORMED.
Description of Event or Problem
THE SET SCREW WOULD NOT START AND ENGAGE THE THREAD OF THE HEAD OF THE ERISMA-LP MIS POLYAXIAL SCREW. THERE WAS A DELAY OF 30 MINUTES ASSOCIATED WITH REMOVING THE SCREW AND REPLACING IT WITH AN ALTERNATIVE PEDICLE SCREW. HOWEVER, NO PATIENT HARM WAS REPORTED AND THE SURGERY COMPLETED WITHOUT FURTHER INCIDENT.
Remedial action
- Replace