LATERAL PATIENT POSITIONING SYSTEM

Additional Manufacturer Narrative

THE DEVICE DID NOT RETURN FOR EVALUATION. PHOTOGRAPHS WERE NOT PROVIDED; THEREFORE, THE COMPLAINT CANNOT BE CONFIRMED. A REVIEW OF DEVICE HISTORY RECORDS SHOWED NO MANUFACTURING OR PROCESSING RELATED IRREGULARITIES. ALPHATEC SPINE IS SUBMITTING THIS REPORT TO COMPLY WITH THE FDA REGULATIONS 21 CFR 803. ALPHATEC SPINE HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS AVAILABLE. ANY FIELD THAT IS LEFT BLANK WAS NOT KNOWN AT THE TIME OF THIS SUBMISSION. IF ADDITIONAL INFORMATION IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

POSTOPERATIVELY, INTERNAL BLEEDING WAS NOTED UNDER THE PATIENT'S RIGHT AXILLA. THE ATTENDING NURSE CONFIRMED THAT THERE WAS NO EVIDENCE OF THIS BLEEDING PRIOR TO THE OPERATION AND INDICATED THAT IT WAS MOST LIKELY ASSOCIATED WITH THE USE OF THE POSITIONER. FOLLOWING THE SURGERY, THE PATIENT REPORTED NO PAIN RELATED TO THIS INCIDENT.