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

Model Number	OXP1525
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
67-year-old female who has sleep apnea and occasionally takes omeprazole.Regular attender to hygienist and periodontist.Had an immediate anthogyr implant placement for the ur1 with horizontal bone augmentation using puros allograft and 15x25 ossix plus membrane stabilized with periosteal sling sutures.The 2-week stitch removal was uneventful, and the patient had no reported pain or swelling at any stages during healing phase.At the 3-month exposure appointment, there was no obvious pus or sinus, but the soft tissue healing was not good and at exposure, soft tissue infil into the graft was discovered.The implant was compromised, with some bone loss at the head of 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: 18862979
• Report Number: 3010626093-2024-00003
• Device Sequence Number: 8282695
• Product Code: NPL
• UDI-Device Identifier: 07290015477765
• UDI-Public: 7290015477765
• 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: 12/11/2025
• Device Model Number: OXP1525
• Device Lot Number: OP1500637
• 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: 67 YR
• Patient Sex: Female