5.5/6.0 UNIAXIAL PEDICLE SCREW 6.0MM X 40MM

Additional Manufacturer Narrative

REFERENCE: (B)(4). CONCOMITANT MEDICAL PRODUCTS: 5.5/6.0 UNIAXIAL PEDICLE SCREW 6.0MM X 40MM, ITEM NUMBER: 00-1300-0640, LOT NUMBER: UNKNOWN. COMPLAINT SAMPLE WAS NOT RETURNED FOR EVALUATION, SCRAPPED BY THE HOSPITAL. REPORTED EVENT WAS CONFIRMED BY REVIEW OF CUSTOMER SUBMITTED RADIOGRAPHS AND CT FILMS. 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 THERE WERE NO TRENDS IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED.

Description of Event or Problem

IT WAS REPORTED THE PATIENT PRESENTED COMPLAINING OF PAIN AT THE LOWER END OF THE IMPLANTED SPINAL CONSTRUCT. RADIOGRAPHS AND CT SCAN SHOWED A LACK OF FUSION AT THE LOWER LEVEL. TWO PEDICLE SCREWS WERE FOUND TO BE BROKEN AND A REVISION SURGERY WAS REQUIRED.