UNSPECIFIED OZARK SCREW
Received Jun 9, 2022 · Event occurred Jan 1, 2022
Report 3004774118-2022-00222 · MDR key 14643500
Device
Generic name
Appliance, Fixation, Spinal Intervertebral Body
Manufacturer
K2m, Inc.Catalog number
UNK_SPE
Lot number
UNKNOWN
Product problems
- Fracture
- Fracture
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE REMAINS IMPLANTED AND WAS THEREFORE NOT RETURNED FOR EVALUATION. DEVICE HISTORY RECORDS AND COMPLAINT HISTORY COULD NOT BE REVIEWED WITHOUT EITHER THE DEVICE OR A VALID LOT NUMBER. LIMITED INFORMATION REGARDING THE EVENT WAS MADE AVAILABLE TO STRYKER. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION, BUT NO RESPONSE WAS RECEIVED. A ROOT CAUSE CANNOT BE ESTABLISHED. IF ADDITIONAL INFORMATION IS RECEIVED OR THE DEVICE IS RETURNED FOR EVALUATION, THE INVESTIGATION WILL BE REOPENED AND UPDATED. DEVICE REMAINS IMPLANTED.
Description of Event or Problem
A COMPANY REPRESENTATIVE REPORTED THAT OZARK SCREW FRACTURES WERE OBSERVED APPROXIMATELY ONE YEAR AFTER IMPLANTATION. THE CONSTRUCT SPANNED C5 TO C7; BILATERAL SCREW FRACTURES WERE NOTED AT THE CRANIAL LEVEL AND A UNILATERAL SCREW FRACTURE WAS NOTED AT THE CAUDAL LEVEL. REVISION SURGERY HAS NOT OCCURRED. THIS REPORT CAPTURES THE THIRD OF THREE SCREWS.