BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: CSLP

    MDR report key: 19559911 · Received June 18, 2024

    Report

    Report Number
    8030965-2024-07607
    Event Type
    Injury
    Date Received
    June 18, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    OVD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. G4 ¿ 510K: THIS REPORT IS FOR AN UNK - CONSTRUCTS: CSLP/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS .BEEN REVIEWED: STEFANIDES, M. ET. AL. ANTERIOR CERVICAL AND UPPER THORACIC COLUMN RECONSTRUCTION USING AN EXPANDABLE POLY-ETHER-ETHER-KETONE VERTEBRAL BODY REPLACEMENT: A RETROSPECTIVE SINGLE CENTER COHORT ANALYSIS. SURG. TECH. DEV. 2024, 13, 107¿121. HTTPS://DOI.ORG/10.3390/STD13020008. OBJECTIVE/METHODS/STUDY DATA: THIS STUDY AIMED TO EVALUATE THE SAFETY AND EFFICACY OF A NOVEL POLY-ETHER-ETHER-KETONE (PEEK) EXPANDABLE VERTEBRAL BODY REPLACEMENT (VBR) FOR ANTERIOR CERVICO-THORACIC VERTEBRAL COLUMN RECONSTRUCTION IN PATIENTS WITH METASTATIC, TRAUMATIC, OR DEGENERATIVE DISEASES. RADIOGRAPHIC AND CLINICAL OUTCOMES, AS WELL AS COMPLICATION RATES, WERE ANALYZED IN A RETROSPECTIVE ANALYSIS OF 28 PATIENTS(61 ± 13 YEARS; 64% FEMALE) WHO UNDERWENT AN ANTERIOR CERVICAL CORPECTOMY AND FUSION (ACCF). THE ECD ( DEPUY SYNTHES SPINE INC., RAYNHAM, MA, USA) WAS IMPLANTED IN ALL CASES IN COMBINATION WITH A TITANIUM (N = 14) OR CARBON (N = 14) ANTERIOR PLATE¿SCREW OSTEOSYNTHESIS (CSLP, DEPUY SYNTHES SPINE INC., RAYNHAM, MA, USA) , USING THE STANDARD ANTERIOR SMITH AND ROBINSON APPROACH FROM JANUARY 2011 UNTIL JUNE 2020 WERE INCLUDED IN THE STUDY. A MINIMUM FOLLOW-UP OF SIX MONTHS WAS DETERMINED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - ARTIFICIAL DISC REPLACEMENT: ECD. (QTY 17) 1 PATIENT HAD EARLY ONSET SURGICAL SITE INFECTION (SSI) AFTER THE INITIAL SURGERY. THE EXPANDABLE CORPECTOMY DEVICE (ECD) HAD TO BE REPLACED. 4 PATIENTS HAD ODYNOPHAGIA WITH NO INTERVENTION REPORTED. 3 PATIENTS HAD DYSPHAGIA WITH NO INTERVENTION REPORTED. 3 PATIENTS HAD HOARSENESS WITH NO INTERVENTION REPORTED. 1 PATIENT HAD AN ESOPHAGEAL PERFORATION REQUIRING MULTIPLE. 3 PATIENTS HAD SURGICAL SITE INFECTION (SSI). TWO OF THE INFECTIONS OCCURRED WITH THE ADDITIONAL POSTERIOR SPONDYLODESIS AN ONE WITH THE ANTERIOR APPROACH. ALL OF THEM REQUIRED REOPERATION. 2 PATIENTS HAD WOUND HEALING DISORDER WITH THE POSTERIOR APPROACH. WOUND REVISION WAS THE INTERVENTION. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: CSLP (QTY 17). 1 PATIENT HAD EARLY ONSET SURGICAL SITE INFECTION (SSI) AFTER THE INITIAL SURGERY. THE EXPANDABLE CORPECTOMY DEVICE (ECD) HAD TO BE REPLACED. 4 PATIENTS HAD ODYNOPHAGIA WITH NO INTERVENTION REPORTED. 3 PATIENTS HAD DYSPHAGIA WITH NO INTERVENTION REPORTED. 3 PATIENTS HAD HOARSENESS WITH NO INTERVENTION REPORTED. 1 PATIENT HAD AN ESOPHAGEAL PERFORATION REQUIRING MULTIPLE REVISION SURGERIES. 3 PATIENTS HAD SURGICAL SITE INFECTION (SSI). TWO OF THE INFECTIONS OCCURRED WITH THE ADDITIONAL POSTERIOR SPONDYLODESIS AN ONE WITH THE ANTERIOR APPROACH. ALL OF THEM REQUIRED REOPERATION. 2 PATIENTS HAD WOUND HEALING DISORDER WITH THE POSTERIOR APPROACH. WOUND REVISION WAS THE INTERVENTION. THIS REPORT IS FOR ONE UNK - CONSTRUCTS: CSLP THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1650945 UNK - CONSTRUCTS: CSLP INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR OVD SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention