MAUDE Adverse Event Report: DATUM DENTAL LTD. OSSIX BONE; BONE GRAFTING MATERIAL, ANIMAL SOURCE

Model Number	OXB0500
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Difficulty Chewing (4522); Osteomyelitis (4533); Swelling/ Edema (4577)
Date of Event	08/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A doctor reported that they removed teeth 15-16 and placed ossix bone in a socket preservation procedure.The doctor did not hydrate the material prior to placement.The patient indicated 3 days post procedure that they developed swelling and were prescribed amoxicillin.At the one-week post-op visit, the doctor noted slight swelling and prescribed the patient medrol dose pack.Later the patient called to indicate their jaw felt stiff and they were prescribed cyclobenzaprine muscle relaxant.The patient later developed swelling at the angle of her mandible and was instructed to go to the emergency room by treating doctor.The treating doctor at the er diagnosed the patient with osteomyelitis and they were referred to an infectious disease specialist who placed the patient on iv antibiotics therapy for 2 days.The patient returned to the reporting office approximately one month post procedure to be seen by the maxillofacial surgeon and they noted there were no signs of osteomyelitis.The wound was reopened and the office performed an irrigation and debridement.The treating office indicated, the patient has not followed up with the infectious disease specialist and is not taking their prescriptions as directed.Regardless, the swelling is resolved and the surgical site is healing well.The office is unsure what caused the osteomyelitis.

• Brand Name: OSSIX BONE
• Common Device Name: BONE GRAFTING MATERIAL, ANIMAL SOURCE
• Manufacturer (Section D): DATUM DENTAL LTD.; 1 bat sheva st.; lod, 71201 0; IS 712010
• Manufacturer (Section G): DATUM DENTAL LTD.; 1 bat sheva st.; lod 71201
• Manufacturer Contact: 1 bat sheva st.; lod, 71201-01
• MDR Report Key: 15577264
• Report Number: 3010626093-2022-00003
• Device Sequence Number: 15299800
• Product Code: NPM
• UDI-Device Identifier: 07290015477253
• UDI-Public: 7290015477253
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K163714
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,User Facility,Distributor
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 10/10/2022

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: 07/12/2024
• Device Model Number: OXB0500
• Device Lot Number: OB50000213
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2022
• Initial Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Female