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

Lot Number OB50000142

Device Problems Failure to Osseointegrate (1863); Appropriate Term/Code Not Available (3191)

Patient Problems Foreign Body Reaction (1868); Inadequate Osseointegration (2646); Swelling/ Edema (4577)

Event Date 05/24/2021

Event Type  Injury  

Manufacturer Narrative

There are a number of well-known postoperative complications with oral surgeries.With time, the ossix¿ bone matrix is resorbed and replaced by new bone as part of the natural healing process.Preclinical studies demonstrated that 50% or greater implant material remain at the 6-month time point.

Event Description

According to the available information, a (b)(6) years old female patient received a bonegraft with ossix bone 5*10*10 (0.5cc) in position 30 (fdi 46) on may 20, 2021.The bonegraft was removed on (b)(6) 2021 as it did not integrate.The bonegraft never integrated, it was lost (almost rejected) from the extraction site.The patient returned four days later with swelling and almost food impaction/dry socket symptoms.The ossix bonegraft partially "flaked" out and was acting more as a foreign body than integrating.It was suctioned out at time of debridement.There are a number of well-known postoperative complications with oral surgeries.With time, the ossix¿ bone matrix is resorbed and replaced by new bone as part of the natural healing process.Preclinical studies demonstrated that 50% or greater implant material remain at the 6-month time point.

• Brand Name: OSSIX BONE
• Type of Device: BONE GRAFTING MATERIAL, ANIMAL SOURCE
• Manufacturer (Section D): DATUM DENTAL LTD.; 1, bat sheva st.; lod, 71201 01; IS 7120101
• MDR Report Key: 12262521
• MDR Text Key: 264705805
• Report Number: 3010626093-2021-00001
• Device Sequence Number: 1
• Product Code: NPM
• Combination Product (y/n): N
• PMA/PMN Number: K163714
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 08/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: OB50000142
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR