MAST QUADRANT RETRACTOR SYSTEM
Received Oct 26, 2020
Report 1030489-2020-01482 · MDR key 10733680
Device
Generic name
Light, Surgical, Carrier
Manufacturer
Warsaw OrthopedicsModel number
9560658Catalog number
9560658
Lot number
0311534W
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Neurological Deficit/Dysfunction
- Neurological Deficit/Dysfunction
Narrative
Additional Manufacturer Narrative
NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH SYMPTOMS OF LUMBAR SPONDYLOLIS THESIS INVOLVED IN OLIF+PPS PROCEDURE USED IN SPINAL THERAPY. LEVELS IMPLANTED: L4/5. IT WAS REPORTED DURING USE, SUPERIOR ADJACENT SEGMENT DISEASE IN PATIENT WAS REPORTED. THERE WAS NO MALFUNCTION OF THE PRODUCT REPORTED. THE BONE WAS FRAGILE ORIGINALLY BECAUSE OF STEROIDS, RHEUMATISM OR DIALYSIS. REMOVAL OF ROD AND SET SCREW WAS PLANNED ON (B)(6) 2020. THERE WAS NO PLAN TO REMOVE CAGE IN REVISION SURGERY. QUANTITY-2 SCREWS WERE REMOVED ON L5, BUT LOT# IS UNKNOWN. THERE WAS NO MALFUNCTION OF IMPLANTED PRODUCTS. OLIF WAS PERFORMED ON L4/5, POSTERIOR SENTANT WAS PERFORMED. DUE TO ADJACENT SEGMENT DISEASE ON L3/4, IT WAS PLANNED TO PERFORM OLIF ON L3/4 AND INSERT PPS IN L3 AND PERFORM CONNECTION ON L3-5 ON (B)(6). ADDITIONAL INFORMATION REGARDING THE RE-OPERATION: BONE FUSION WAS ACHIEVED COMPLETELY ON L4/5, SCREW ON L5 WAS REMOVED. OLIF WAS PERFORMED BETWEEN L3/4, POSTERIOR FUSION ON L3/4 WITH PPS WAS PERFORMED AND THE OPERATION WAS COMPLETED. PATIENT STATUS IS UNKNOWN, BUT MOVEMENT OF LEG RIGHT AFTER THE OPERATION WAS WELL.