MAUDE Adverse Event Report: DATUM DENTAL LTD. OSSIX PLUS; RESORBABLE COLLAGEN MEMBRANE

Model Number	OXP1525
Health Effect - Clinical Codes	Purulent Discharge (1812); Unspecified Infection (1930); Impaired Healing (2378)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the dentist used the membrane over bone graft and at the time of implant placement, tissue died back over the membrane.Bone was exposed and the dental implant failed.The patient had poor healing and dentist is concerned about residual eto in the membrane.Update on 8/26/2016: the implant which underwent concomitant guided bone regeneration had an infection and implant failure.The membrane became exposed and dissolved.Patient was placed on zithromax and all adverse events have resolved.This ae is slightly possibly related to the ossix plus and more likely not related to the membrane or the eto.Update on 9/1/2016: the doctor placed 7 implants in a patient and one implant which underwent concomitant guided bone regeneration had an infection and implant failure.The initial infection started around the soft tissue, patient was placed on zithromax (penicillin allergy), then switched to metronidazle.Implant failed in 2 weeks when became loose, then second implant 2 weeks later.The doctor feels the implants were placed according to acceptable surgical protocol.The ae resolved and the patient is fine.Update on 9/14/2016: the dentist clarified that there was no tissue necrosis.She said there was pus and infection.

• Brand Name: OSSIX PLUS
• Common Device Name: RESORBABLE COLLAGEN MEMBRANE
• Manufacturer (Section D): DATUM DENTAL LTD.; 1, bat sheva st.; lod, 71201 01; IS 7120101
• MDR Report Key: 5964939
• Report Number: 3010626093-2016-00001
• Device Sequence Number: 661408
• Product Code: NPL
• UDI-Device Identifier: 07290015477727
• UDI-Public: 07290015477727
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K053260
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 09/20/2016

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
• Operator of Device: Dentist
• Device Expiration Date: 09/30/2016
• Device Model Number: OXP1525
• Device Lot Number: OP141948
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2016
• Initial Report FDA Received Date: 09/20/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BONE GRAFT; DENTAL IMPLANT
• Outcome Attributed to Adverse Event: Required Intervention