MAUDE Adverse Event Report: INION OY INION GTR BIODEGRADABLE SYSTEM; TACK

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Wound Dehiscence (1154); Erosion (1750); Foreign Body Reaction (1868); Impaired Healing (2378)

Event Type  Injury  

Event Description

Purpose of this study was to evaluate whether or not the use of a xenogeneic block loaded with rhbmp 2 results in superior radiological and profilometric outcomes compared to an autogenous bone block in ridge augmentation.24 patients were treated with xenogeneic block loaded with rhbmp 2 (test group) or autogenous block (control group).The augmented area was covered with a native collagen membrane, which was immobilized by inion gtr tacks.In one patient in the control group, the augmentation procedure failed with the autogenous bone block being exposed 6 days after surgery.Due to an ineffective antiseptic treatment, the block had to be removed after 21 days to allow for adequate wound healing.The augmentation procedure was successful with other 23 patients.

Manufacturer Narrative

In this study, inion gtr tacks were used to immobilize the membrane covering the augmented area of each patient.In one patient in the control group, the augmentation procedure failed with the autogenous bone block being exposed 6 days after surgery.Due to an ineffective antiseptic treatment, the block had to be removed after 21 days to allow for adequate wound healing.In this study, the reason for the block exposure remained unclear.The study did not report that the inion gtr tacks immobilizing collagen membrane would have failed and caused the exposure of the autogenous block.However, the inion tack might have contributed to the event, as explanation for the block exposure was not reported in the study.Since the patient with the failed augmentation refused to undergo another surgical procedure, he was excluded from the present study.In 23 out of 24 patients originally included to the study, the augmentation procedure was successful.

• Brand Name: INION GTR BIODEGRADABLE SYSTEM
• Type of Device: TACK
• Manufacturer (Section D): INION OY; lääkärinkatu 2; tampere, 33520 ; FI 33520
• Manufacturer (Section G): INION OY; lääkärinkatu 2; tampere, 33520 ; FI 33520
• Manufacturer Contact: kati marttinen ; lääkärinkatu 2; tampere, 33520 ; FI 33520
• MDR Report Key: 15937853
• MDR Text Key: 305047425
• Report Number: 3003407235-2022-00003
• Device Sequence Number: 1
• Product Code: NPK
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K033074
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 12/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2022
• 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: Initial
• Patient Sequence Number: 1
• Treatment: BIO-OSS GRANULAT, GEISTLICH PHARMA AG; BIO-OSS SPONGIOSA BLOCK, GEISTLICH PHARMA AG; MEMBRANE, BIOGIDE GEISTLICH PHARMA AG; SCREWS GBR SYSTEM, INSTITUTE STRAUMANN AG
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR