InjuryOSH
RESPONSE LARGE SET SCREW
Received May 1, 2019 · Event occurred Mar 25, 2019
Report 3006460162-2019-00015 · MDR key 8571189
Device
Generic name
Pedicle Screw Spinal System
Manufacturer
Orthopediatrics, IncModel number
N/ACatalog number
00-1003-4001
Lot number
M69067-B
Product problems
- Fracture
- Fracture
Patient
17 YR
- Pain
- Pain
Narrative
Additional Manufacturer Narrative
REFERENCE: (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ORTHOPEDIATRICS FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT FOLLOWING A POSTERIOR FUSION SURGERY, THE PATIENT EXPERIENCED BACK PAIN AND CLICKING. IT WAS DISCOVERED DURING THE REVISION PROCEDURE THAT A SET SCREW WAS LOOSE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.