Description of Event or Problem · 0
DISTRIBUTOR REPORTED ON (B)(6) 2025 THAT THERE WAS A BROKEN PS8 FOUND IN AN X-RAY ON (B)(6) 2025 AFTER THE PATIENT ARRIVED AT A FOLLOW-UP APPOINTMENT REPORTING PAIN. THE ORIGINAL IMPLANT DATE WAS (B)(6) 2025 AND IT WAS STATED THAT ACCORDING TO THE ATTENDING PHYSICIAN, THE PATIENT WAS NOT VERY COOPERATIVE WITH THE POST-OPERATIVE PROTOCOL. THEREFORE, AFTER THE SURGERY BUT PRIOR TO THE FOLLOW UP X-RAY, THE DOCTOR DECIDED TO APPLY AN ACRYLIC PLASTER CAST TO IMMOBILIZE THE WRIST AND FOREARM. THE BROKEN PLATE WAS DISCOVERED AFTER THE PLASTER CAST WAS APPLIED SO THE DOCTOR REQUESTED SURGICAL INTERVENTION ON (B)(6) 2025 FOR THE REMOVAL OF MATERIAL AND THAT THE PATIENT REQUESTED THE CHANGE OF MATERIAL TYPE FROM STEEL TO TITANIUM. IT WAS REPORTED TO TRIMED ON (B)(6) 2025, THAT THERE IS NO EVIDENCE SUGGESTING A PRODUCT DEFECT. PRELIMINARY INFORMATION INDICATES THAT THE PATIENT SUFFERED A FALL POSTOPERATIVELY, WHICH MAY EXPLAIN THE EVENT. HOWEVER, THE CASE IS BEING FOLLOWED LOCALLY FOR A COMPLETE EVALUATION. THERE WAS ABOUT A 0-5 MINUTE DELAY IN SURGERY DUE TO THE SURGEONS SCHEDULE BUT THE REMOVAL WAS SUCCESSFUL. DUE TO PATIENT DISCOMFORT AND NON-UNION THERE IS A REPORTED ADVERSE EVENT.