ORTHOPEDIATRICS RESPONSE LARGE SET SCREW

Additional Manufacturer Narrative

REFERENCE: (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ORTHOPEDIATRICS FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT FOLLOWING THE PLACEMENT OF A RESPONSE SPINE CONSTRUCT, TWO SET SCREWS WERE DISCOVERED TO BE DISENGAGED. THE PATIENT WAS SUCCESSFULLY REVISED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.