MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,literatur report with the FDA on 2018-06-14 for CALCIUM HYDROXYLAPATITE manufactured by Merz North America, Inc..
[111145118]
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.
Patient Sequence No: 1, Text Type: N, H10
[111145119]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2135225-2018-00031 |
| MDR Report Key | 7602751 |
| Report Source | HEALTH PROFESSIONAL,LITERATUR |
| Date Received | 2018-06-14 |
| Date of Report | 2018-06-14 |
| Date Mfgr Received | 2018-04-24 |
| Date Added to Maude | 2018-06-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SCOTT SYKES, MD |
| Manufacturer Street | 6501 SIX FORKS ROAD |
| Manufacturer City | RALEIGH NC 27615 |
| Manufacturer Country | US |
| Manufacturer Postal | 27615 |
| Manufacturer Phone | 9195828000 |
| Manufacturer G1 | MERZ NORTH AMERICA, INC. |
| Manufacturer Street | 4133 COURTNEY STREET, SUITE 10 |
| Manufacturer City | FRANKSVILLE WI 53126 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53126 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CALCIUM HYDROXYLAPATITE |
| Generic Name | POLYMER, ENT SYNTHETIC-POLYAMIDE (MESH OR FOIL MATERIAL) |
| Product Code | KHJ |
| Date Received | 2018-06-14 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERZ NORTH AMERICA, INC. |
| Manufacturer Address | 4133 COURTNEY STREET, SUITE 10 FRANKSVILLE WI 53126 US 53126 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2018-06-14 |