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

Lot Number OB50000213

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Laceration(s) (1946); Muscular Rigidity (1968); Osteomyelitis (4533); Swelling/ Edema (4577)

Event Date 08/18/2022

Event Type  Injury  

Event 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, thee 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
• Type of Device: BONE GRAFTING MATERIAL, ANIMAL SOURCE
• Manufacturer (Section D): DATUM DENTAL LTD; 1 bat sheva st., po box 6170; lod 71160 03; IS 7116003
• MDR Report Key: 15562445
• MDR Text Key: 301354102
• Report Number: 3009443653-2022-00001
• Device Sequence Number: 1
• Product Code: NPM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163714
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 10/07/2022,09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: OB50000213
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/07/2022
• Distributor Facility Aware Date: 09/09/2022
• Event Location: Other
• Date Report to Manufacturer: 10/07/2022
• Date Manufacturer Received: 09/09/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female