INFUSE BONE GRAFT UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03 report with the FDA on 2014-12-18 for INFUSE BONE GRAFT UNK manufactured by Medtronic Sofamor Danek Usa, Inc.

Event Text Entries

[5138268] It was reported that infants underwent nasoalveolar molding/gingivoperiosteoplasty (gpp) with bmp-2 on a resorbable matrix for primary alveolar repair. Long-term follow-up (10 years) was compared for no gpp, gpp only or gpp with bmp-2 by analyzing alveolar bone, tooth eruption, and maxillary growth. For the three primary unilateral cleft repair patient groups: no gpp (n =15), gpp only (n = 15) or gpp with bmp-2 (n = 10) follow-up studies were performed at least 10 years after the procedure. There was one gpp patient lost to follow-up. The study recorded need for secondary alveolar bone grafting, timing of tooth eruption, and clinical evidence of maxillary hypoplasia. New-tom scans were used to analyze dentition, bone volume and bone density. Greater bone graft volume/density was seen at the cleft site in group 3 (gpp/bmp-2) compared to group 2 (gpp only) (86% vs 42% bone fill). Secondary alveolar bone grafting after expansion was necessary in group 1 (100%); group 2 (73%); group 3 (20%). Two patients in group 3 (gpp/bmp-2) underwent le fort i distraction at age 13. In the other groups there were no patients, to date, who have undergone le fort i distraction. Clinical evidence of maxillary hypoplasia was seen in group 1 (40%); group 2 (53%); group 3 (60%). It was concluded that after mid-childhood but prior to skeletal maturity, gpp/bmp-2 primary alveolar cleft repairs showed similar tooth eruption, improved bone fill of the cleft site, less need for secondary alveolar grafting. However, data thus far shows poorer midface growth compared to no gpp at primary cleft repair. Two patients in the bmp cohort required secondary alveolar bone grafting after expansion.
Patient Sequence No: 1, Text Type: D, B5


[12620541] (b)(4). Neither the device nor applicable imaging study films or patient medical records were returned to the manufacturer for evaluation. Therefore, we are unable to determine the definitive cause of the reported event. Products from multiple manufacturers were implanted/used during the procedure. Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1030489-2014-04791
MDR Report Key4343524
Report Source03
Date Received2014-12-18
Date of Report2014-11-26
Date of Event2014-05-01
Date Mfgr Received2014-11-26
Date Added to Maude2014-12-19
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactHUZEFA MAMOOLA
Manufacturer Street1800 PYRAMID PLACE
Manufacturer CityMEMPHIS TN 38132
Manufacturer CountryUS
Manufacturer Postal38132
Manufacturer Phone9013963133
Manufacturer G1MEDTRONIC SOFAMOR DANEK
Manufacturer Street1800 PYRAMID PLACE
Manufacturer CityMEMPHIS TN 38132
Manufacturer CountryUS
Manufacturer Postal Code38132
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameINFUSE BONE GRAFT
Generic NameBONE GRAFTING MATERIAL, DENTAL, WITH BIOLOGIC COMPONENT
Product CodeNPZ
Date Received2014-12-18
Model NumberNA
Catalog NumberUNK
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC SOFAMOR DANEK USA, INC
Manufacturer Address4340 SWINEA RD MEMPHIS TN 38118 US 38118


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2014-12-18

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.