BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CALCIUM HYDROXYLAPATITE

    MDR report key: 7602751 · Received June 14, 2018

    Report

    Report Number
    2135225-2018-00031
    Event Type
    Injury
    Date Received
    June 14, 2018
    Report Date
    June 14, 2018
    Manufacturer
    MERZ NORTH AMERICA, INC.
    Product Code
    KHJ
    PMA / PMN Number
    K013243
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CASE WAS ASSESSED AS REPORTABLE TO THE FDA AS THE EVENT, MODERATE OBSTRUCTIVE SLEEP APNEA WAS DEEMED TO MEET SERIOUS INJURY CRITERIA OF NECESSITATING MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE. THE DEVICE HISTORY RECORD FOR CALCIUM HYDROXYLAPATITE COULD NOT BE REVIEWED AS THE BRAND NAME OR LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED PER LITERATURE ARTICLE: CALCIUM HYDROXYLAPATITE INJECTION FOR PERSISTENT VELOPHARYNGEAL INSUFFICIENCY AFTER SPHINCTER PHARYNGOPLASTY, LITERATURE JOURNAL: ORL 2015, EDITION 77, PAGE NUMBERS 155 TO 161, AUTHORS: DR. BRENDAN P O'CONNELL, AMIT J SOOD, DAVID A GUDI, MELISSA MONTIEL, DAVID R WHITE. THIS REPORT CONCERNS ONE OF UNKNOWN NUMBER OF PATIENTS (CHILDREN) FOR WHICH NO DEMOGRAPHICS WERE PROVIDED. THIS LITERATURE REPORT FROM USA CONCERNS A PATIENT WHO WAS INJECTED TRANSORALLY WITH CALCIUM HYDROXYLAPATITE INTO SPHINCTER PHARYNGOPLASTY (SP) FLAPS FOR PERSISTANT VELOPHARYNGEAL INSUFFICIENCY (VPI). AFTER ORAL INTUBATION, THE PATIENT WAS PLACED IN THE OPERATING TABLE IN SUPINE POSITION WITH A SHOULDER ROLL. THE NOSE WAS DECONGESTED WITH OXYMETAZOLINE. A CROW DAVIS MOUTH GAG WAS INSERTED INTO THE ORAL CAVITY EXPOSING THE OROPHARYNX, AND A RED RUBBER CATHETER WAS INSERTED THROUGH THE NOSE AND PULLED OUT THE MOUTH RETRACTING THE SOFT PALATE. A ZERO DEGREE TELESCOPE WAS INSERTED INTO THE NOSE AND POSITIONED AT THE CHOANA TO ALLOW VISUALIZATION OF SPHINCTER PHARYNGOPLASTY FLAPS. A 21 GAUGE, 1.5 INCH NEEDLE WAS PASSED TRANSORALLY AND USED TO INJECT CALCIUM HYDROXYLAPATITE INTO THE SPHINCTER PHARYNGOPLASTY FLAPS (ALSO REPORTED AS VELOPHARYNGEAL PORT) UNDER ENDOSCOPIC GUIDANCE. THE LOCATION OF THE INJECTION DEPENDED ON THE FINDING FROM PREOPERATIVE CLINIC ENDOSCOPY. THERE WERE NO INTRAOPERATIVE OR IMMEDIATE POSTOPERATIVE COMPLICATIONS ASSOCIATED WITH CALCIUM HYDROXYLAPATITE INJECTION. SPECIFICALLY, NO IMPLANT MIGRATION OR INFECTION WAS NOTED. A NOTABLE INCREASE IN BULK OF THE FLAPS COULD BE OBSERVED IMMEDIATELY AFTER THE PROCEDURE. PREOPERATIVELY AND WITHIN SIX MONTHS POSTOPERATIVELY, THE PATIENT UNDERWENT EVALUATION THAT INCLUDED PERCEPTUAL ANALYSIS AND THE MACKAY KUMMER SIMPLIFIED ASSESSMENT PROCEDURE TEST R. AFTER THE TREATMENT WITH CALCIUM HYDROXYLAPATITE, THE PATIENT DEVELOPED MODERATE OBSTRUCTIVE SLEEP APNEA (OSA). AT THE INITIAL FOLLOW UP, THE PATIENT DEMONSTRATED NO IMPROVEMENT IN HYPERNASALANCE. CORRECTIVE TREATMENT INCLUDED TONSILLECTOMY WITH RESOLUTION OF OSA. AT THE TIME OF THE LAST FOLLOW-UP, THE PATIENT HAD UNDERGONE FORMAL REVISION SP, REPORTEDLY TO ADDRESS PERSISTENT LATERAL GAPS ON ENDOSCOPY. THE OUTCOME OF THE EVENT 'NO IMPROVEMENT IN HYPERNASALANCE' WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444955 CALCIUM HYDROXYLAPATITE POLYMER, ENT SYNTHETIC-POLYAMIDE (MESH OR FOIL MATERIAL) KHJ MERZ NORTH AMERICA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R