MalfunctionOSH
RESPONSE 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 35MM
Received Feb 14, 2020 · Event occurred Jan 10, 2020
Report 3006460162-2020-00007 · MDR key 9714167
Device
Generic name
Pedicle Screw Spinal System
Manufacturer
Orthopediatrics, CorpModel number
N/ACatalog number
00-1300-0735
Lot number
200269-L
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
13 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). PRODUCT HAS BEEN RECEIVED BY ORTHOPEDIATRICS AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
Description of Event or Problem
IT HAS BEEN REPORTED THAT DURING THE PLACEMENT OF A UNIAXIAL PEDICLE SCREW, THE SCREW HEAD DISASSEMBLED FROM THE SHAFT OF THE SCREW. THE SCREW WAS REMOVED AND A NEW SCREW IMPLANTED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.