BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHORELINE ACS, WAVEFORM C

    MDR report key: 23536318 · Received November 12, 2025

    Report

    Report Number
    3012120772-2025-00060
    Event Type
    Injury
    Date Received
    November 12, 2025
    Report Date
    January 28, 2026
    Manufacturer
    SEASPINE ORTHOPEDICS CORPORATION
    Product Code
    OVE
    PMA / PMN Number
    K161081
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTER RETURNED A SHORINSTFX INSTRUMENT SET FOR ANALYSIS WHICH THEY SAID WAS THE MOST COMMONLY USED BY THEM. HOWEVER, THE REPORTER DID NOT CONFIRM THAT THIS SHORINSTFX INSTRUMENT SET WAS THE ONE USED IN ANY OF THE THREE REPORTED CASES. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. THIS INCLUDED CLARIFICATION ON THE RATIONALE FOR THE HOSPITAL SUSPECTING DEVICE INVOLVEMENT, WHETHER OTHER SUPPLIERS' INVENTORY WAS ALSO UNDER CONSIDERATION, AS WELL AS REPROCESSING DETAILS. NO FURTHER INFORMATION WAS PROVIDED. THEREFORE, THE COMPLAINTS CANNOT BE CONFIRMED OR ATTRIBUTED TO MANUFACTURING AT THIS TIME. POSSIBLE ADVERSE EVENTS: SERIOUS COMPLICATIONS ASSOCIATED WITH ANY SURGERY MAY OCCUR. THESE INCLUDE, BUT ARE NOT LIMITED TO: WOUND COMPLICATIONS, INFECTION, GENITOURINARY DISORDERS, GASTROINTESTINAL DISORDERS, RESPIRATORY DISORDERS; CARDIOVASCULAR DISORDERS, INCLUDING MYOCARDIAL INFARCTION (HEART ATTACK) OR ARRYTHMIAS; NEUROLOGIC INJURIES RESULTING IN WEAKNESS, PARALYSIS, NUMBNESS, TINGLING, OR PAIN; VASCULAR (BLOOD VESSEL) INJURIES, INCLUDING HEMORRHAGE (BLEEDING); THROMBOSIS (BLOOD CLOTS) LEADING TO DEEP VENOUS THROMBOSIS OR PULMONARY EMBOLISM; OR DEATH.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW IT WAS DETERMINED THAT THE RETURNED SHORINSTFX INSTRUMENT SET WAS NOT UTILIZED IN ANY OF THE 3 CASES. THEREFORE, THIS SET WAS ERRONEOUSLY RETURNED FOR ANALYSIS. NO FURTHER INFORMATION WAS PROVIDED. THEREFORE, THE ROOT CAUSE OF THE COMPLAINTS CANNOT BE CONFIRMED OR ATTRIBUTED TO A MANUFACTURING DEFECT RELATED TO AN ORTHOFIX DEVICE AT THIS TIME. POSSIBLE ADVERSE EVENTS: SERIOUS COMPLICATIONS ASSOCIATED WITH ANY SURGERY MAY OCCUR. THESE INCLUDE, BUT ARE NOT LIMITED TO: WOUND COMPLICATIONS, INFECTION, GENITOURINARY DISORDERS, GASTROINTESTINAL DISORDERS, RESPIRATORY DISORDERS; CARDIOVASCULAR DISORDERS, INCLUDING MYOCARDIAL INFARCTION (HEART ATTACK) OR ARRYTHMIAS; NEUROLOGIC INJURIES RESULTING IN WEAKNESS, PARALYSIS, NUMBNESS, TINGLING, OR PAIN; VASCULAR (BLOOD VESSEL) INJURIES, INCLUDING HEMORRHAGE (BLEEDING); THROMBOSIS (BLOOD CLOTS) LEADING TO DEEP VENOUS THROMBOSIS OR PULMONARY EMBOLISM; OR DEATH.

    Description of Event or Problem · 0

    ON 17-OCT-2025 ORTHOFIX BECAME AWARE OF THREE POST-OPERATIVE INFECTIONS ASSOCIATED WITH SURGICAL CASES UTILIZING THE WAVEFORM C AND SHORELINE FIXATION SYSTEMS. THIS REPORT IS FOR THE 3RD OUT OF THE 3 REPORTED INFECTIONS. THE INITIAL SURGERY DATE FOR THIS REPORT WAS NOT PROVIDED. NO FURTHER DETAILS REGARDING THE PATIENT STATUS WERE RECEIVED, ALTHOUGH MULTIPLE ATTEMPTS WERE MADE. THE CUSTOMER DID NOT SPECIFY ANY PARTICULAR PART NUMBERS AS HAVING CAUSED THE INFECTIONS. HENCE THIS REPORT IS BEING SUBMITTED FOR BOTH WAVEFORM C AND SHORELINE FIXATION SYSTEMS, THE 501(K) CODES ARE K212904 AND K161081 RESPECTIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2644654 SHORELINE ACS, WAVEFORM C INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL OVE SEASPINE ORTHOPEDICS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other