RESPONSE SPINE 5.5, SET SCREW, SMALL
Received Feb 23, 2020
Report 3006460162-2019-00041 · MDR key 9742964
Device
Generic name
Pedicle Screw Spinal System
Manufacturer
Orthopediatrics, IncModel number
N/ACatalog number
00-1003-3012
Lot number
UNKNOWN
Product problems
- Fracture
- Fracture
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). CONCOMITANT PRODUCT: ITEM: 00-1300-5028, FIXED CROSS CONNECTOR, 28MM, LOT: UNKNOWN. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED.
Description of Event or Problem
IT WAS REPORTED THAT DURING THE PLACEMENT OF A RESPONSE SPINAL CONSTRUCT, A SMALL SET SCREW SHEERED OFF AND WAS LEFT IN THE PATIENT. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.