RESPONSE SPINE SET SCREW
Received Dec 14, 2018
Report 3006460162-2018-00075 · MDR key 8166128
Device
Generic name
Pedicle Screw Spinal System
Manufacturer
Orthopediatrics, IncModel number
N/ACatalog number
UNKNOWN
Lot number
UNKNOWN
Product problems
- Migration
- Migration
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ORTHOPEDIATRICS FOR INVESTIGATION AS IT IS STILL IMPLANTED. THE EVENT WAS CONFIRMED VIA COMMUNICATION WITH THE SURGEON, HOWEVER ITEM AND LOT NUMBERS WERE NEVER RECEIVED. 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. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ORTHOPEDIATRICS WILL CONTINUE TO MONITOR FOR TRENDS.
Description of Event or Problem
IT HAS BEEN REPORTED THAT SEVERAL MONTHS FOLLOWING THE PLACEMENT OF A RESPONSE SPINE SYSTEM, A SET SCREW WAS DISCOVERED TO BE LOOSE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.