MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Edema (1820)

Event Date 07/01/2014

Event Type  Injury  

Event Description

It was reported that a case series study was conducted.The case series evaluated the treatment outcome of maxillary anterior lateral ridge augmentation with rhbmp-2/acs, using support screws for space maintenance.Twenty patients with a maxillary anterior deficient edentulous ridge spanning two or more tooth sites or requiring extraction of two or more contiguous teeth with 50% or greater vertical alveolar buccal cortical plate loss (dehiscence) were treated.Mucoperiosteal flaps were reflected after a beveled palatal incision over the defect crest, crevicular incisions at adjacent teeth, and vertical releasing incisions were made.Teeth requiring extraction were removed atraumatically.Following debridement, bone-block fixation screws (straumann) were inserted into the alveolar ridge approximately 4 mm from the ridge crest.In general, one fixation screw was used for each edentulous space; however, in concave defects occasionally two fixation screws were used.The rhbmp-2/acs (infuse bone graft, medtronic) was prepared according to manufacturer instructions and cut into squares for ease of use.The graft was compressed until it extended above the fixation screws.The mucoperiosteal flaps were repositioned and sutured with expanded polytetrafluoroethylene (ptfe) sutures.Postsurgical periorbital edema was observed in all but two surgeries performed and resolved completely within 2 weeks.

Manufacturer Narrative

Article citation: edmunds et al.Maxillary anterior ridge augmentation with recombinant human bone morphogenetic protein 2.Int j periodontics restorative dent 2014;34:551¿557.Age range 33-73 yrs.(b)(4).Neither the device nor films of applicable imaging studies 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 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.

• Brand Name: INFUSE BONE GRAFT
• Type of Device: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 4192422
• MDR Text Key: 17995331
• Report Number: 1030489-2014-04095
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 07/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/15/2014
• Initial Date FDA Received: 10/22/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other