5.5/6.0 UNIAXIAL PEDICLE SCREW 6MM X 40MM

Additional Manufacturer Narrative

THIS FOLLOW IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: B6 UPDATED CUSTOMER PROVIDED RADIOGRAPHS, DATES (B)(6) 2018, (B)(6) 2018 AND (B)(6) 2019, AP AND LATERAL VIEWS. H6 UPDATED METHOD 4109, 4114 AND 4119. H6 UPDATED RESULTS 3252. H6 UPDATED CONCLUSION 4315. COMPLAINT SAMPLE WAS NOT RETURNED FOR EVALUATION. REPORTED EVENT WAS CONFIRMED THROUGH RADIOGRAPHIC IMAGES PROVIDED BY THE CUSTOMER. DHR REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE INVOLVED DEVICE IS UNKNOWN. 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 MEDICAL PRODUCTS: ITEM 00-1300-0635, 5.5/6.0 UNIAXIAL PEDICLE SCREW 6MM X 35MM, LOT: UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ORTHOPEDIATRICS FOR INVESTIGATION AS IT IS STILL IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 3006460162-2019-00029.

Description of Event or Problem

IT WAS REPORTED THAT APPROXIMATELY ONE YEAR FOLLOWING THE PLACEMENT OF A RESPONSE SPINE CONSTRUCT, TWO SCREWS AT THE BOTTOM OF THE CONSTRUCT WERE NOTED TO BE FRACTURED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.