MalfunctionOSH
RESPONSE UNIAXIAL SCREW 6.0MM X 45MM
Received Mar 22, 2019
Report 3006460162-2019-00010 · MDR key 8445519
Device
Generic name
Pedicle Screw Spinal System
Manufacturer
Orthopediatrics, IncModel number
N/ACatalog number
00-1003-4390
Lot number
M54988-B
Product problems
- Fracture
- Fracture
Patient
14 YR
- No Information
- No Information
Narrative
Additional Manufacturer Narrative
(B)(4). THE PRODUCT HAS NOT BEEN RETURNED TO ORTHOPEDIATRICS AS IT REMAINS IMPLANTED. 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 FOLLOWING THE PLACEMENT OF A RESPONSE SPINE CONSTRUCT, A SET SCREW WAS FOUND TO BE LOOSE. A FRACTURED SCREW WAS ALSO REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.