IDENTITI ALIF INTERBODY SYSTEMS
Received Apr 30, 2025 · Event occurred Mar 31, 2025
Report 2027467-2025-00077 · MDR key 21934953
Device
Generic name
Elevator
Manufacturer
Alphatec Spine, Inc.Model number
168-30Catalog number
168-30
Lot number
FD9618711
Product problems
- Break
- Material Separation
- Break
- Material Separation
Patient
NA · Unknown
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A DISTRACTOR BROKE DURING A CASE. A SPRING FROM THE DISTRACTOR WAS LEFT IN THE PATIENT.
Additional Manufacturer Narrative
THE DEVICE IS CURRENTLY BEING EVALUATED. A FOLLOW-UP REPORT WITH THE RESULTS OF THE INVESTIGATION WILL BE SUBMITTED UPON COMPLETION.
Additional Manufacturer Narrative
CORRECTION: H3. YES H6. INVESTIGATION FINDINGS: 3252 INVESTIGATION CONCLUSIONS: 61 DEVICE EVALUATION: VISUAL INSPECTION CONFIRMS THE COMPLAINT. THE PADDLE HAS SHEARED FROM ONE OF THE DISTRACTOR ARMS. THE PADDLE WAS RETURNED, BUT THE SPRING FOR THE BUTTON WAS NOT. THE ROOT CAUSE IS LIKELY THAT THE INSTRUMENT WAS TWISTED WHILE ATTEMPTING TO DISTRACT THE DISC SPACE CAUSING EXCESS LOAD FROM THIS TORSION AND BENDING. REVIEW OF DEVICE HISTORY RECORDS SHOWED NO MANUFACTURING IRREGULARITIES. LABELING REVIEW: WARNINGS/CAUTIONS/PRECAUTIONS: POTENTIAL RISKS IDENTIFIED WITH THE USE OF THESE FUSION DEVICES, WHICH MAY REQUIRE ADDITIONAL SURGERY, INCLUDE DEVICE COMPONENT FAILURE, LOSS OF FIXATION, PSEUDARTHROSIS (I.E., NON-UNION), FRACTURE OF THE VERTEBRA, NEUROLOGICAL INJURY, AND/OR VASCULAR OR VISCERAL INJURY. POSSIBLE ADVERSE EFFECTS: INITIAL OR DELAYED LOOSENING, BENDING, DISLOCATION, AND/OR BREAKAGE OF DEVICE COMPONENTS. PHYSIOLOGICAL REACTION TO IMPLANT DEVICES DUE TO FOREIGN BODY INTOLERANCE INCLUDING INFLAMMATION, LOCAL TISSUE REACTION, SEROMA, AND POSSIBLE TUMOR FORMATION.