BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SOLERA VOYAGER SPINAL SYSTEM

    MDR report key: 19402430 · Received May 27, 2024

    Report

    Report Number
    1030489-2024-00580
    Event Type
    Injury
    Date Received
    May 27, 2024
    Date of Event
    May 7, 2024
    Report Date
    July 25, 2024
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    NKB
    UDI-DI
    00763000211196
    PMA / PMN Number
    K201362
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3. PRODUCT ANALYSIS PRODUCT ID :6541101, LOT NO: H5792406 VISUAL AND OPTICAL EXAMINATION REVEALED THAT THERE WERE NO SIGNS OF THREAD DAMAGE ON THE SET SCREW. THE THREADS APPEAR TO BE USED BUT NO SIGNS OF CROSS THREADING. FUNCTIONAL EVALUATION OF THE RETURNED IMPLANT WITH A SAMPLE BONE SCREW CONFIRMED THE SET SCREW WAS ABLE TO ENGAGE AND THREAD INTO THE HEAD OF THE BONE SCREW WITHOUT ISSUE. THE BOTTOM NODE OF THE SET SCREW SHOWS SIGNS OF OFF AXIS/ UNEVEN WEAR FROM THE SEATING OF THE ROD. THERE IS SOME SMEARING / DAMAGED TO THE NODES AND THE SCREW SADDLES FROM WHAT APPEARS TO BE THE RODS MOVING BETWEEN THE SADDLES AND SET SCREW. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 6541101, SERIAL/LOT #: (B)(6), UBD: 21-SEP-2027, UDI #: (B)(4), 510(K): K201362. PRODUCT ID: 55750017545, SERIAL/LOT #: (B)(6), UBD: 14-MAR-2031, UDI #: (B)(4), 510(K): K170679. PRODUCT ID: 55750017545, SERIAL/LOT #: (B)(6), UBD: 26-JUL-2031, UDI #: (B)(4), 510(K): K170679. PRODUCT ID: 7078396, SERIAL/LOT #: (B)(6), UBD: 06-DEC-2031, UDI #: (B)(4), 510(K): K202328. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D10: PRODUCT ID: 7078396, SERIAL/LOT #: (B)(6) (QUANTITY: 2) WAS NOT A DEFECTIVE PRODUCT. RADIOGRAPHIC IMAGE REVIEW: AP LUMBAR INTERBODY FUSION, ONE OF THE SET SCREWS ON THE SUPERIOR LEVEL IS OUT OF THE SCREW TULIP LATERAL VIEW OF 1, THE CONSTRUCT APPEARS INTACT. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    H3. PRODUCT ID : 6541101, LOT NO.: H5792410. VISUAL AND OPTICAL EXAMINATION REVEALED THAT THERE WERE NO SIGNS OF THREAD DAMAGE ON THE SET SCREW. THE THREADS APPEAR TO BE USED BUT NO SIGNS OF CROSS THREADING. FUNCTIONAL EVALUATION OF THE RETURNED IMPLANT WITH A SAMPLE BONE SCREW CONFIRMED THE SET SCREW WAS ABLE TO ENGAGE AND THREAD INTO THE HEAD OF THE BONE SCREW WITHOUT ISSUE. THE BOTTOM NODE OF THE SET SCREW SHOWS SIGNS OF OFF AXIS/ UNEVEN WEAR FROM THE SEATING OF THE ROD. THERE IS SOME SMEARING/DAMAGED TO THE NODES AND THE SCREW SADDLES FROM WHAT APPEARS TO BE THE RODS MOVING BETWEEN THE SADDLES AND SET SCREW. PRODUCT ID : 55750017545 LOT NO.: H5841874 VISUAL AND OPTICAL EXAMINATION REVEALED THAT THERE WERE NO SIGNS OF THREAD DAMAGE ON THE SET SCREW. THE THREADS APPEAR TO BE USED BUT NO SIGNS OF CROSS THREADING. FUNCTIONAL EVALUATION OF THE RETURNED IMPLANT WITH A SAMPLE BONE SCREW CONFIRMED THE SET SCREW WAS ABLE TO ENGAGE AND THREAD INTO THE HEAD OF THE BONE SCREW WITHOUT ISSUE. THE BOTTOM NODE OF THE SET SCREW SHOWS SIGNS OF OFF AXIS/ UNEVEN WEAR FROM THE SEATING OF THE ROD. THERE IS SOME SMEARING/DAMAGED TO THE NODES AND THE SCREW SADDLES FROM WHAT APPEARS TO BE THE RODS MOVING BETWEEN THE SADDLES AND SET SCREW. PRODUCT ID : 55750017545 LOT NO.: H5878308 VISUAL AND OPTICAL EXAMINATION REVEALED THAT THERE WERE NO SIGNS OF THREAD DAMAGE ON THE SET SCREW. THE THREADS APPEAR TO BE USED BUT NO SIGNS OF CROSS THREADING. FUNCTIONAL EVALUATION OF THE RETURNED IMPLANT WITH A SAMPLE BONE SCREW CONFIRMED THE SET SCREW WAS ABLE TO ENGAGE AND THREAD INTO THE HEAD OF THE BONE SCREW WITHOUT ISSUE. THE BOTTOM NODE OF THE SET SCREW SHOWS SIGNS OF OFF AXIS/ UNEVEN WEAR FROM THE SEATING OF THE ROD. THERE IS SOME SMEARING/DAMAGED TO THE NODES AND THE SCREW SADDLES FROM WHAT APPEARS TO BE THE RODS MOVING BETWEEN THE SADDLES AND SET SCREW. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING PLIF FOR SPINAL CANAL STENOSIS. IT WAS REPORTED THAT SET SCREWS DISLODGED AND REPLACEMENT SURGERY OCCURRED. THE SCREWS WERE LOOSE AND REPLACED. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624152 CD HORIZON SOLERA VOYAGER SPINAL SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB MDT SOFAMOR DANEK PUERTO RICO MFG 6541101 H5792406 00763000211196

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention "SEE H11."