5.5/6.0 UNIAXIAL REDUCTION PEDICLE SCREW 6.0MM, 45MM
Received Dec 23, 2019 · Event occurred Nov 23, 2019
Report 3006460162-2019-00081 · MDR key 9512202
Device
Generic name
Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
Manufacturer
Orthopediatrics, IncModel number
N/ACatalog number
00-1300-0645
Lot number
194216-L
Product problems
- Use of Device Problem
- Use of Device Problem
Patient
35 YR
- Pain
- Pain
Narrative
Additional Manufacturer Narrative
(B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL 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 HAS BEEN REPORTED THAT FOLLOWING THE PLACEMENT OF A SPINAL CONSTRUCT, THE PATIENT WAS REVISED DUE TO PAIN. IT WAS NOTED THAT THE PEDICLE SCREW PLACED AT THE LEFT L4 PEDICLE WAS TOO FAR MEDIAL. IT WAS REVISED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.