FDA Adverse Event Injury Summary report: N

NBX NON-BRIDGING FRACTURE FIXATION SHOULDER

MDR report key: 7159770 · Received January 3, 2018

Report

Report Number
7159770
Event Type
Injury
Date Received
January 3, 2018
Date of Event
November 17, 2017
Report Date
December 15, 2017
Manufacturer
NUTEK ORTHOPAEDICS, INC.
Product Code
KTT
Adverse Event
Yes
Report Source
User Facility report
Reporter Location
AZ, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

THE PATIENT FELL ON HER RIGHT ARM AT HOME IN LATE (B)(6), WAS SEEN IN ER AND FOUND ON X-RAY TO HAVE COMPLETE FRACTURE THROUGH THE SURGICAL NECKS OF THE PROXIMAL HUMERUS WITH SIGNIFICANT DISLOCATION, MULTIPART HUMERAL HEAD FRACTURE; IMMOBILIZER PLACED, REFERRED TO ORTHO SURGERY. THREE DAYS AFTER THE FALL, THE PATIENT HAD OUTPATIENT SURGERY: RIGHT PROXIMAL HUMERUS EXTERNAL FIXATOR APPLICATION WITH CLOSED REDUCTION UNDER GENERAL ANESTHESIA WITH AN INTERSCALENE BLOCK; IMPLANTS USED: NBX PROXIMAL HUMERUS EXTERNAL FIXATOR WITH QUANTITY OF SIX 3MM STEINMANN PINS AND QUANTITY OF TWO 4MM STEINMANN PINS. IN MID-(B)(6), THE PATIENT HAD OUTPATIENT SURGERY: RIGHT PROXIMAL HUMERUS EXTERNAL FIXATOR REMOVAL. IN MID-(B)(6), THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR RIGHT SHOULDER PAIN, SYMPTOMS CONSISTENT WITH SEPTIC ARTHRITIS AND OSTEOMYELITIS IN THE RIGHT SHOULDER AFTER EXTERNAL FIXATOR REMOVAL. THE FOLLOWING DAY, THE PATIENT HAD SURGERY: RIGHT SHOULDER ARTHROSCOPY WITH IRRIGATION AND DEBRIDEMENT, EXTENSIVE SYNOVECTOMY OF THE GLENOHUMERAL JOINT AND SUBACROMIAL SPACE; RIGHT SHOULDER SYNOVECTOMY AND CHONDROPLASTY; OPEN RIGHT HUMERUS IRRIGATION AND DEBRIDEMENT WITH BONE BIOPSY. TWO DAYS AFTER ADMISSION, INFECTIOUS DISEASE (I.D.) CONSULTATION: APPEARS TO BE A POSTOPERATIVE SEPTIC ARTHRITIS OF THE RIGHT SHOULDER, STATUS POST FRACTURE AND EXTERNAL FIXATION WITH OSTEOMYELITIS AND PRESUMED STAPHYLOCOCCAL INFECTION; RECOMMENDATIONS FOR PICC LINE AND 6 WEEKS ANTIBIOTIC THERAPY. FOUR DAYS AFTER ADMISSION, THE PATHOLOGY REPORT SIGNED FOR THE BONE BIOPSY: NEGATIVE FOR ACUTE OSTEOMYELITIS. THE FOLLOWING DAY, THE PATIENT DISCHARGED HOME WITH HOME HEALTH. PER I.D. PHYSICIAN IMPRESSION: (B)(6) OSTEO; GROWING (B)(6) FROM OP CULTURE; CHANGE FROM VANCO TO CEFAZOLIN THROUGH THE NEW YEAR.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
4212 NBX NON-BRIDGING FRACTURE FIXATION SHOULDER APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL CO KTT NUTEK ORTHOPAEDICS, INC. NPUE150702

Patients

Seq Age Sex Outcome Treatment
1 61 YR Hospitalization| R NO OTHER THERAPIES| THERE WERE OTHER DEVICES AND SUPPLIES IN USE DURING