UNKNOWN RESPONSE SPINE 5.5/6.0 UNIAXIAL PEDICLE SCREW
Received Jan 12, 2018 · Event occurred May 22, 2017
Report 3006460162-2018-00003 · MDR key 7186969
Device
Generic name
Pedicle Screw Spinal System
Manufacturer
Orthopediatrics, CorpModel number
N/ACatalog number
UNKNOWN
Lot number
UNKNOWN
Product problems
- Fracture
- Fracture
Patient
17 YR
- No Information
- No Information
Narrative
Additional Manufacturer Narrative
(B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ORTHOPEDIATRICS FOR INVESTIGATION AS IT IS STILL 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 A SPINAL DEFORMITY CORRECTION PROCEDURE, AN X-RAY TAKEN POST-OPERATIVELY REVEALED A FRACTURED PEDICLE SCREW. THE SHANK OF THE SCREW FRACTURED POST FUSION ON THE BOTTOM OF THE CONSTRUCT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.