MAST QUADRANT™ Retractor System 9560658Recalls & reported problems
Medtronic Sofamor Danek, Inc. · INSTRUMENT 9560658 QUADRANT ILLUMIN SYS · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885074042497), received between Oct 26, 2020 and Oct 26, 2020 — classified as 1 injury.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Neurological Deficit/Dysfunction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use 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.
Patient problems: Neurological Deficit/Dysfunction
MAUDE report 10733680 ↗
Other PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER devices
- ATTUNE 1512-14-050Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER106 reports
- ATTUNE 1504-40-205Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall53 reports
- ATTUNE 1504-40-105Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall46 reports
- ATTUNE 1547-06-001Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall37 reports
- ATTUNE 1513-12-060Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER72 reports
- Triathlon 5521-B-300Howmedica Osteonics Corp. · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall19 reports
- Triathlon 5531-G-709-EHowmedica Osteonics Corp. · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall19 reports
- ATTUNE 1512-16-080Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall16 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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