MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG MEDPOR TITAN SHEET - MTB - 38M; IMPLAINT

Catalog Number 81026

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

Patient Problems Inflammation (1932); Irritation (1941)

Event Date 12/14/2016

Event Type  malfunction  

Manufacturer Narrative

The device is not available for evaluation.If additional information is received it will be reported on a supplemental report.The product was sent to biologics.

Event Description

It was reported by a company representative that after initial implantation of medpor on (b)(6) a revision surgery was required due to inflammation/irritation.The revision surgery took place on (b)(6) in order to remove the medpor, and it was completed successfully.

• Brand Name: MEDPOR TITAN SHEET - MTB - 38M
• Type of Device: IMPLAINT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• Manufacturer Contact: gregory gohl ; boetzingerstr. 41; freiburg D-791-11 ; 76145120
• MDR Report Key: 6213606
• MDR Text Key: 63821786
• Report Number: 0008010177-2016-00309
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040364
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 81026
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/14/2016
• Initial Date FDA Received: 12/29/2016
• Was Device Evaluated by Manufacturer?: No
• 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