THE INFORMATION PROVIDED FROM THE REPORTER AND THE CENTINEL RM SUGGEST THAT MEDICAL INTERVENTION WAS REQUIRED TO PRECLUDE A SERIOUS INJURY AS A RESULT OF THE MILLING BIT MALFUNCTION. THE PRODISC C IMPLANT WAS REPLACED WITH AN UNKNOWN TITANIUM CAGE WITH ILIAC ALLOGRAFT. THE PATIENT HAS BEEN REPORTED TO BE RECOVERING OK AND WAS DISCHARGED FROM THE FACILITY. THE PATIENT WAS SAID TO BE A LARGE INDIVIDUAL WITH HARD/DENSE BONE. DHR REVIEW DID NOT IDENTIFY ANY ANOMALIES IN MANUFACTURING THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE MALFUNCTION. THE RISK ASSESSMENT FOUND THAT ASSOCIATED RISKS ARE IDENTIFIED, MITIGATED, AND DETERMINED TO BE ACCEPTABLE. REVIEW OF PREVIOUS COMPLAINTS FOUND THE RATE OF COMPLAINTS IS WITHIN ALLOWABLE LIMITS. NO CAPAS HAVE BEEN RELATED TO THIS COMPLAINT. EVALUATION OF THE RETURNED BROKEN TIP CONFIRMED THE MALFUNCTION. THE SHAFT/REMAINDER OF THE INSTRUMENT WAS NOT RETURNED FOR EVALUATION. THE RETURNED TIP WAS FOUND TO BE IN SPECIFICATION. THERE IS NO INDICATION OF A DEVICE RELATED PROBLEM.
D
Patient 1
PATIENT HAVING A PRODISC C US IMPLANTATION AT C5-C6. PROCEDURE WAS PERFORMED ON (B)(6) 2020. WHILE THE SURGEON WAS CUTTING THE KEEL FOR THE PDC, THE PRODISC C 1.8MM MILLING BIT BROKE WITHIN THE KEEL CUT. THE SURGEON DID NOT REALIZE THE BIT BROKE, AND IMPLANTED A PDC US XLD 5MM IMPLANT. THE IMPLANT PUSHED THE BROKEN TIP OF THE MILLING BIT INTO THE PATIENT'S SPINAL CANAL CAUSING A DURA TEAR AND CEREBRAL SPINAL FLUID LEAK. MILLING BIT WAS LOCATED VIA ANTERIOR X-RAY IMAGING. LATERAL X-RAYS APPEARED NORMAL. THE SURGEON EXPLANTED THE PDC DEVICE AND REMOVED THE BROKEN TIP FROM THE PATIENT. THE DURA TEAR WAS REPAIRED TO STOP THE CSF LEAK. THE PATIENT WAS SHOWING SIGNS OF COMPARTMENT SYNDROME AND INCREASED PRESSURES; HOWEVER THE PRESSURES STARTED TO DECREASE. THE SURGEON IMPLANTED A TITANIUM CAGE AND ALLOGRAFT IN PLACE OF THE PRODISC C DEVICE. AS OF (B)(6) 2020, THE PATIENT IS DOING OK AND WAS DISCHARGED. NO FURTHER DETAILS WERE PROVIDED ON THE PATIENT STATUS.