LARGE SET SCREW

Additional Manufacturer Narrative

THE FOLLOW IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: D4 UPDATED LOT NUMBER M69068-B. D4 UPDATED UDI (B)(4). H4 UPDATED 31 JAN 2017. H6 UPDATED METHOD 3331, 4109 AND 10. H6 UPDATED RESULTS 3207. H6 UPDATED CONCLUSION 4315 AND 50. COMPLAINT SAMPLE WAS RETURNED FOR EVALUATION. REPORTED EVENT WAS CONFIRMED. INVESTIGATION OF THE DHR DID NOT REVEAL ANY PROCESS DEVIATIONS OR INDICATIONS OF MANUFACTURING VARIATIONS THAT WOULD CONTRIBUTE TO THE OBSERVED FAILURE MODE. RISK MANAGEMENT FILE REVIEW WAS DEEMED APPROPRIATE. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED.

Additional Manufacturer Narrative

(B)(4). CONCOMITANT DEVICES: ITEM: 00-1003-4001, LARGE SET SCREW, LOT: UNKNOWN, ITEM: 00-1300-2850, 5.5/6.0 POLYAXIAL PEDICLE SCREW 8.0MM X 50MM, LOT: 160069-G, ITEM: 00-1300-0740, 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 40MM, LOT: M849321-I, ITEM: 00-1300-0745, 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 45MM, LOT: M78684-I. PRODUCT HAS BEEN RECEIVED BY ORTHOPEDIATRICS AND 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 A SPINAL FUSION, THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO SET SCREW LOOSENING. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.