MAUDE Adverse Event Report: STRYKER ORTHOBIOLOGICS-MALVERN MEDPOR TITAN SHEET - MTM - 76M; IMPLANT

Catalog Number 81020

Device Problem Insufficient Information (3190)

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930)

Event Date 04/07/2016

Event Type  Injury  

Manufacturer Narrative

Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.Product was discarded.

Event Description

It was reported by a sales representative that after a procedure the patient had experienced a wound dehiscence.The medpor product was removed from the infection site and then discarded.The revision surgery took place within 90 days of the original surgery date which was (b)(6) 2016.

• Brand Name: MEDPOR TITAN SHEET - MTM - 76M
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOBIOLOGICS-MALVERN; 45 great valley parkway; malvern PA 19355
• Manufacturer (Section G): STRYKER ORTHOBIOLOGICS-MALVERN; 45 great valley parkway; malvern PA 19355
• Manufacturer Contact: hans geiger ; boetzingerstr. 41; freiburg D-791-11 ; 76145120
• MDR Report Key: 5884233
• MDR Text Key: 52379137
• Report Number: 0008010177-2016-00190
• 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: 07/22/2016

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: 81020
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/22/2016
• Initial Date FDA Received: 08/17/2016
• 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