RESPONSE 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 45MM

Additional Manufacturer Narrative

REFERENCE: (B)(4). CONCOMITANT PRODUCT: ITEM NUMBER: 00-1003-4001, RESPONSE LARGE SET SCREW, LOT NUMBER: M56976-B, ITEM NUMBER: 00-1003-4001, RESPONSE LARGE SET SCREW, LOT NUMBER: M55906-A, ITEM NUMBER: 00-1300-0745, RESPONSE 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 45MM, LOT NUMBER: 041824-E, ITEM NUMBER: UNKNOWN, UNKNOWN RESPONSE 6.0 COCR ROD, LOT NUMBER: UNKNOWN, ITEM NUMBER: UNKNOWN, UNKNOWN RESPONSE 6.0 COCR ROD, LOT NUMBER: UNKNOWN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3006460612-2019-00084, 3006460612-2019-00085, AND 3006460612-2019-00087.

Description of Event or Problem

IT HAS BEEN REPORTED THAT FOLLOWING THE PLACEMENT OF A RESPONSE SPINAL CONSTRUCT, THE PATIENT UNDERWENT A REVISION DUE TO ROD FRACTURE AND DISENGAGEMENT. DURING THE REVISION IT WAS NOTED THAT TWO PEDICLE SCREWS WERE REPLACED DUE TO WEAR. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

Additional Manufacturer Narrative

THE FOLLOW IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CORRECTION: A4 107 KG. UPDATED: H4 UPDATED 05 JUN 2015. H6 UPDATED METHOD 3331, 4109 AND 10. H6 UPDATED RESULTS 140. H6 UPDATED CONCLUSION 4315. COMPLAINT SAMPLE WAS RETURNED FOR EVALUATION. THE COMPLAINT WAS CONFIRMED. DHR REVIEW: PRODUCT AND PROCESS SHOW CONFORMING. THERE WERE NO RECENT DESIGN CHANGES PRIOR TO MANUFACTURING. 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.