5.5/6.0 UNIAXIAL PEDICLE SCREW 6MM X 35MM
Received Jul 3, 2019
Report 3006460162-2019-00029 · MDR key 8760796
Device
Generic name
Pedicle Screw Spinal System
Manufacturer
Orthopediatrics, IncModel number
N/ACatalog number
00-1300-0635
Lot number
UNKNOWN
Product problems
- Fracture
- Fracture
Patient
19 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM 00-1300-0640, 5.5/6.0 UNIAXIAL PEDICLE SCREW 6MM X 40MM, LOT: UNKNOWN. 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 WAS REPORTED THAT APPROXIMATELY ONE YEAR FOLLOWING THE PLACEMENT OF A RESPONSE SPINE CONSTRUCT, TWO SCREWS AT THE BOTTOM OF THE CONSTRUCT WERE NOTED TO BE FRACTURED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.