MAUDE Adverse Event Report: TUTOGEN MEDICAL GMBH COPIOS PERICARDIUM MEMBRANE; DENTAL MEMBRANE

Lot Number NZA19150184

Device Problem Insufficient Information (3190)

Patient Problem Failure of Implant (1924)

Event Date 01/04/2021

Event Type  Injury  

Manufacturer Narrative

Unique identifiers have not provided to date, in order to conduct a comprehensive records re-review.If additional information becomes available, a follow up report will be submitted.

Event Description

Rti surgical, inc (rti) and tutogen medical gmbh (tmi), a wholly subsidiary of rti, received a complaint on (b)(6) 2021.The reported complaint indicated that a patient underwent a dental procedure with implantation of a copios® pericardium membrane, a puros® customized block allograft and a spongiosa particles allograft.The doctor indicated that there was non integration of tissue.To date, additional information has not been provided.

Manufacturer Narrative

Rti germany conducted a batch documentation review for serial id (b)(6) manufactured from lot nza19150184.One departure from standard operating procedures was noted during the records re-review that would not negatively impact the manufacturing of copios pericardium membrane xenografts from lot nza19150184 (nc 19 35 072: missing datalogger data for cooling chamber f28-b).Manufacturing records review indicated that serial id (b)(6) was manufactured to specification and met all acceptance / inspection criteria prior to distribution.To date, rti germany has manufactured and distributed 60 copios pericardium membrane xenografts from lot nza19150184 without related complaints.Non-integration of xenografts is a well-known phenomenon.Several reasons have been described, e.G.Diabetes, allergic reactions to bovine material, bruxism and bad mouth hygiene.It was reported that the patient did not have any respective medical history or social circumstances that may have contributed to the event.Importantly, it was reported that the membrane was not rehydrated prior to use and therefore was not used according the instructions given in the ifu.This is considered a strong cause for non­ integration and considered as off-label use.Although implant therapy is highly successful and predictable, it is not without possible early and/or late complications.Examples include non-adherence to implant package insert instructions.It is more plausible that the patient's non-integration of tissue is associated with a source or event extrinsic to the graft.

• Brand Name: COPIOS PERICARDIUM MEMBRANE
• Type of Device: DENTAL MEMBRANE
• Manufacturer (Section D): TUTOGEN MEDICAL GMBH; industriestrabe 6; neunkirchen am brand, 91077 ; GM 91077
• Manufacturer Contact: karen britt ; 11621 research circle; alachua, FL 32615 ; 3864188888
• MDR Report Key: 11860134
• MDR Text Key: 255954374
• Report Number: 3002924436-2021-00014
• Device Sequence Number: 1
• Product Code: NPL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K142070
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: NZA19150184
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/20/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/30/2019
• 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: 52 YR
• Patient Sex: Female