THOMPSON SURGICAL INSTRUMENTS

Additional Manufacturer Narrative

THE DEVICE NOR LOT INFORMATION WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. INITIAL REPORTER (HEALTH PROFESSIONAL) INFORMATION WAS NOT PROVIDED TO MANUFACTURER SO PROVIDED THE NAME OF THE REPORTER THAT MADE CONTACT WITH THOMPSON SURGICAL INSTRUMENTS. THOMPSON SURGICAL INSTRUMENTS SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PART 803. THIS REPORTING IS ALSO A RESULT OF A CONTAINMENT ACTION OF AN INTERNAL PROCESS NOT REALIZING REPORTING REQUIREMENTS PER INTERNAL FINDINGS WITHIN CORRECTIVE ACTION CAR 2026004. THOMPSON MADE REASONABLE EFFORTS TO RECEIVE THE PRODUCT BACK AND PROVIDE AS MUCH RELEVANT INFORMATION. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, THOMPSON SURGICAL INSTRUMENTS, OR ITS EMPLOYEES THAT THE DEVICE, THOMPSON SURGICAL INSTRUMENTS, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. THOMPSON SURGICAL INSTRUMENTS WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

Description of Event or Problem

ON 2025-FEB-14 MPXR 1272358 (REP, HCP, FOR): INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH CAGE HAVING SPINAL THERAPY FOR INTESTINAL INJURY, IT WAS REPORTED THAT A PATIENT WHO UNDERWENT SURGERY (FM/T3) YESTERDAY WAS SUSPECTED OF HAVING INTESTINAL DAMAGE. DUE TO THE SUSPICION OF INTESTINAL DAMAGE, THE SURGICAL DOCTOR PERFORMED AN OPERATION TO RESECTION THE BOWEL AND REPLACED IT WITH ARTIFICIAL ANUS. IT WAS SPECULATED BY THE ORTHOPEDIC DOCTOR THAT A RETRACTOR OR SOMETHING SIMILAR MIGHT HAVE INJURED THE INTESTINE DURING THE INITIAL T3 OPERATION. NO SYMPTOMS WERE PRESENT WHEN THE INITIAL SURGERY CONCLUDED YESTERDAY. IT IS ANTICIPATED THAT SYMPTOMS MIGHT HAVE APPEARED FROM POST OPERATION (INITIAL OPERATION) TO THIS NEXT DAY MORNING. THE SURGICAL OPERATION WAS PERFORMED WITHOUT THE REMOVAL OF THE T3. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ON 2025-FEB-19 ARED (REP): ADDITIONAL INFORMATION RECEIVED THAT IT IS NOT CLEAR WHETHER THE CAUSE WAS THE RETRACTION. IT IS UNKNOWN WHICH INSTRUMENT ACTUALLY CAUSED THE INTESTINAL DAMAGE. THERE ARE NO DEFECTS IN THE IMPLANTS USED. THE REASON FOR THE REMOVAL IS THAT BACTERIA MAY BE ATTACHED TO THE IMPLANT DUE TO INTESTINAL DAMAGE. THE PATIENT WAS STILL IN THE ICU. ON 2025-FEB-26 ARED (REP): ADDITIONAL INFORMATION RECEIVED THAT RETRACTORS WERE PATCHED AND USED REGULARLY AND WILL NOT BE RETURNED.