MAUDE Adverse Event Report: DATUM DENTAL LTD. OSSIX BONE 5*5*10 (0.25 CC); BONE GRAFTING MATERIAL, ANIMAL SOURCE

Catalog Number OXB0250

Device Problem Osseointegration Problem (3003)

Patient Problem Inadequate Osseointegration (2646)

Event Type  Injury  

Event Description

Doctor reported that they had been using ossix bone since (b)(6) 2021 and six months later going back in and finding voids in the areas.

• Type of Device: BONE GRAFTING MATERIAL, ANIMAL SOURCE
• Manufacturer (Section D): DATUM DENTAL LTD.; 1, bat sheva st.; lod hamerkaz 71201 01; IS 7120101
• MDR Report Key: 14844681
• MDR Text Key: 294882376
• Report Number: 1222802-2022-00003
• Device Sequence Number: 1
• Product Code: NPM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 06/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: OXB0250
• Device Lot Number: OB25000225
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention