MAUDE Adverse Event Report: DATUM DENTAL LTD. OSSIX PLUS; Barrier, animal source, intraoral

Model Number	OXP2530
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Impaired Healing (2378)
Type of Reportable Event	Serious Injury
Event or Problem Description
66-year-old female with past cancer hx but in remission.No meds contra indicating implant placement.Had a single anthogyr delayed implant placed in the ll6 site with no threads exposed, but with need for horizontal bone augmentation.This was undertaken with puros allograft particles and the 25x 30 mm ossix plus membrane stabilized with periosteal sling sutures.The implant and graft were buried and the closure achieved by primary stability.The 2-week stitch removal was uneventful and the patient had no pain at any stages.At the 3-month exposure appointment, the site had a sinus tract with pus discharge and the bone graft and implant were completely compromised.There was soft tissue instead of new bone and when this was removed , buccal and vertical bone loss was evident; doctor explanted the implant.

• Brand Name: OSSIX PLUS
• Common Device Name: Barrier, animal source, intraoral
• Manufacturer (Section D): DATUM DENTAL LTD.; 1, bat sheva st.; lod, 71201 01; IS 7120101
• Manufacturer (Section G): DATUM DENTAL LTD.; 1, bat sheva st.; lod, 71201 01; IS 7120101
• Manufacturer Contact: 1, bat sheva st.; lod, 71201-01
• MDR Report Key: 18862975
• Report Number: 3010626093-2024-00002
• Device Sequence Number: 15524415
• Product Code: NPL
• UDI-Device Identifier: 07290015477727
• UDI-Public: 7290015477727
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K160281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 03/07/2024

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: Health Professional
• Device Expiration Date: 12/25/2025
• Device Model Number: OXP2530
• Device Lot Number: OP2500647
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2024
• Initial Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ANTHOGYR IMPLANT, PUROS ALLOGRAFT PARTICLES
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR
• Patient Sex: Female