MalfunctionOSH
UNKNOWN RESPONSE PEDICLE SCREW
Received Mar 12, 2019 · Event occurred Feb 11, 2019
Report 3006460162-2019-00009 · MDR key 8414468
Device
Generic name
Pedicle Screw Spinal System
Manufacturer
Orthopediatrics, IncModel number
N/ACatalog number
UNKNOWN
Lot number
UNKNOWN
Product problems
- Fracture
- Fracture
Patient
Not reported
- No Information
- No Information
Narrative
Additional Manufacturer Narrative
REFERENCE: (B)(4). CUSTOMER HAS NOT RETURNED THE DEVICE 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 HAS BEEN REPORTED THAT FOLLOWING THE PLACEMENT OF RESPONSE SPINE CONSTRUCT, A SCREW BROKE IN THE PEDICLE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.