MAUDE Adverse Event Report: REOSS GMBH YXOSS CBR; TITANMESH

Model Number C8742A

Device Problem Product Quality Problem (1506)

Patient Problem Failure of Implant (1924)

Event Date 05/25/2022

Event Type  Injury  

Event Description

Reoss gmbh produced titanium mesh for bone augmentation in the jaw region.Each mesh is designed according to the customer`s specific needs based on cbct images.In this case, the designer turned the jaw to the wrong side in our design program and created the mesh for teeth 29,30 instead of 19,20.(there were large defect regions on both sides of the patient, which helped the mix-up.After the 3d design of the mesh is ready, it is sent to the doctor.He can make changes or if the design fits, he must approve the design.The doctor also did not realize it was the wrong side when reviewing the design and approved.During the surgery, when he was going to put the mesh in, he realized it did not fit.He was trying to get the mesh to fit from every angle possible.During this manipuliation he damaged the tooth 21.He thereafter made the decision to remove and graft intraoperatively with the patient's consent.

• Brand Name: YXOSS CBR
• Type of Device: TITANMESH
• Manufacturer (Section D): REOSS GMBH; echterdinger str. 57.; filderstadt, baden-württemberg 70794 ; GM 70794
• Manufacturer (Section G): REOSS GMBH; echterdinger str. 57; filderstadt, baden-württemberg 70794 ; GM 70794
• Manufacturer Contact: veronika mayer ; echterdinger str. 57.; filderstadt, baden-württemberg 70794 ; GM 70794
• MDR Report Key: 16040162
• MDR Text Key: 306067323
• Report Number: 3017734069-2022-00001
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192747
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 06/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: C8742A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2022
• 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
• Patient Outcome(s): Other
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian