PYRAMESH IMPLANT SYSTEM

Additional Manufacturer Narrative

THIS PRODUCT IS NOT APPROVED FOR SALE IN US BUT A SIMILAR DEVICE WITH CATALOG NUMBER 905-320 AND 510K NUMBER K890601 IS APPROVED FOR SALE IN US. (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

Description of Event or Problem

IT WAS REPORTED THAT ON (B)(6) 2016, PATIENT UNDERWENT C3/5 ANTERIOR CERVICAL DISKECTOMY AND FUSION (ACDF) AND POSTERIOR SPINAL FUSION. ON AN UNKNOWN DATE, POST-OP, ONE SCREW IN THE RIGHT SIDE OF CAUDAL PORTION BACKED OUT. IN ADDITION, THE SPINAL CAGE MIGRATED. THE DURA MATER WAS COMPRESSED BY THE CAGE AND NUMBNESS OF THE HAND HAD WORSENED (ON AN UNKNOWN DATE), THEREAFTER THE PATIENT UNDERWENT X-RAY ON (B)(6) 2016 WHICH REVEALED THAT THE IMPLANTS HAD DISLOCATED. THEREFORE, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2016. IN WHICH ALL THE IMPLANTS WERE REPLACED. THE PATIENT UNDERWENT SPINAL FUSION DUE TO TRAUMA. THE PATIENT HAD INSTABILITY IN POSTERIOR COMPONENTS INCLUDING FACET JOINT AND HAD POOR BONE. PLATE COULDN'T BE WELL SEATED ON THE BONE DUE TO ITS UNFAVORABLE SHAPE. ALL THE IMPLANTS WERE REMOVED. THERE WAS PROLONGATION OF HOSPITALIZATION DUE TO THE REVISION SURGERY AND THERE WAS A DELAY OF MORE THAN 60 MINUTES IN OVERALL PROCEDURE IN THE REVISION SURGERY. DOCTOR¿S COMMENT: "IT COULDN'T BE DETERMINED WHICH OCCURRED FIRST BACK-OUT OF SCREW OR CAGE MIGRATION. THE ROCK SCREW MAY HAVE NOT BEEN STEADILY TIGHTENED."

Additional Manufacturer Narrative

IMAGE REVIEW: POST-OP, PRE-REVISION X-RAYS PROVIDED AFTER C3-5 ANTERIOR STABILIZATION OF TRAUMATIC FRACTURE WITH C4 CORPECTOMY. THESE SHOW FAILURE OF THE CONSTRUCT WITH CAGE MIGRATION. PER COMMENTS STRUCTURES WERE DISRUPTED POSTERIORLY AND SOME DIFFICULTY WAS ENCOUNTERED WITH PLATE PLACEMENT AT INITIAL SURGERY. THIS SUGGEST THAT 360 DEGREE CONSTRUCT WOULD HAVE BEEN APPROPRIATE INITIALLY.

Additional Manufacturer Narrative

A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.