UNKNOWN ORTHOPEDIATRICS PEDICLE SCREW
Received Feb 24, 2020
Report 3006460162-2019-00063 · MDR key 9744126
Device
Generic name
Pedicle Screw Spinal System
Manufacturer
Orthopediatrics, IncModel number
N/ACatalog number
UNKNOWN
Lot number
UNKNOWN
Product problems
- Fracture
- Fracture
Patient
16 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). REPORTER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ORTHOPEDIATRICS FOR INVESTIGATION AS IT REMAINS IMPLANTED.
Description of Event or Problem
IT HAS BEEN REPORTED THAT FOLLOWING THE PLACEMENT OF A SPINAL CONSTRUCT, A SCREW WAS NOTED TO HAVE FRACTURED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Additional Manufacturer Narrative
THE FOLLOW IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: H6 UPDATED METHOD 4114 4119. H6 UPDATED RESULTS 3252. H6 UPDATED CONCLUSION 4315. COMPLAINT SAMPLE WAS NOT RETURNED FOR EVALUATION. REPORTED EVENT WAS NOT CONFIRMED. DHR REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE INVOLVED DEVICE IS UNKNOWN. RISK MANAGEMENT FILE REVIEW WAS DEEMED APPROPRIATE. ROOT CAUSE WAS UNABLE TO BE DETERMINED.