MAUDE Adverse Event Report: RTI SURGICAL, INC TUTOPATCH BOVINE PERICARDIUM

Lot Number NOT PROVIDED

Device Problems Human-Device Interface Problem (2949); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 08/08/2016

Event Type  Injury  

Manufacturer Narrative

Product identifiers (serial id and lot number) were not provided.Therefore, an investigation and re-review of manufacturing records could not be conducted.Although the surgeon utilized the tutopatch in a personalized unique method, the use of tutopatch as a covering membrane sutured to the periosteum, is not contraindicated.The surgeon was trying to achieve a watertight closure, which is not possible.As there was no information regarding rupture or resorption of the membrane, it can be assumed that the fluid escaped via the suture points.In cases where a watertight closure is required (i.E.Duraplasty) , water tightness is achieved by utilizing a sealing agent to prevent leakage via the suture points.Not available for evaluation.

Event Description

Rti surgical, inc (rti) and tutogen medical (b)(4) a wholly owned subsidiary of rti, received a complaint on 08/18/2016 reporting that a tutopatch bovine pericardium was utilized as a barrier after removal of a malignant tumor (site unknown) and filling with a synthetic bone void filler (cerament).The surgeon's expectations were not met.Additional information received indicated that the tutopath was used as a periosteum substitute after removal of a tumor.The surgeon applied a personalized multilayer technique using autologous tissue as well as synthetic material, the latter being loaded with antibiotics.In order to avoid flushing of the antibiotics, the surgeon used the tutopatch as a cover of the multilayer filling material, with the expectation that it would be watertight.

• Brand Name: TUTOPATCH BOVINE PERICARDIUM
• Type of Device: BOVINE PERICARDIUM
• Manufacturer (Section D): RTI SURGICAL, INC; 11621 research circle; alachua FL 32615
• Manufacturer (Section G): RTI SURGICAL, INC; 11621 research circle; alachua FL 32615
• Manufacturer Contact: leila kelly ; 11621 research circle; alachua, FL 32615 ; 3864188888
• MDR Report Key: 5956818
• MDR Text Key: 54940648
• Report Number: 3002924436-2016-00010
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K081538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other