InjuryOSH
UNKNOWN RESPONSE PEDICLE SCREW
Received Jul 7, 2019 · Event occurred Jun 6, 2019
Report 3006460162-2019-00032 · MDR key 8766133
Device
Generic name
Pedicle Screw Spinal System
Manufacturer
Orthopediatrics, IncModel number
N/ACatalog number
UNKNOWN
Lot number
UNKNOWN
Product problems
- Fracture
- Fracture
Patient
16 YR
- No Information
- No Information
Narrative
Additional Manufacturer Narrative
(B)(4). THE PRODUCT HAS NOT BE RETURNED TO ORTHOPEDIATRICS FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT FOLLOWING THE PLACEMENT OF RESPONSE SPINE CONSTRUCT, THE PATIENT WAS REVISED DUE TO FRACTURED PEDICLE SCREWS. THE PATIENT HAD THREE PEDICLE SCREWS REVISED. NO OTHER PATIENT CONSEQUENCES WERE REPORTED.