MAUDE Adverse Event Report: KARL LEIBINGER MEDIZINTECHNIK GMBH AND CO. KG STERNAL TALON; STERNAL FIXATION DEVICE

Model Number 24-009-14-71

Device Problem Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Laceration(s) (1946)

Event Date 10/31/2014

Event Type  Injury  

Event Description

Three sternal talons were implanted for sternal closure.Patient returned to doctor after 18 hours due to irregular blood amounts being removed.Patient underwent second surgery and doctor discovered a small puncture slit on an artery running along the left ventricular artery.The talons were removed and the puncture slit was stitched up.The patient was reported as doing well following second surgery.

Manufacturer Narrative

Device is not available for evaluation.If further information is acquired that adds value to the content of this report and/or a valid conclusion can be drawn, a follow-up report will be sent.

• Brand Name: STERNAL TALON
• Type of Device: STERNAL FIXATION DEVICE
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH AND CO. KG; kolbinger strabe 10; muhlheim/donau ; GM
• Manufacturer (Section G): KARL LEIBINGER MEDIZINTECHNIK GMBH AND CO. KG; kolbinger strabe 10; muhlheim/donau ; GM
• Manufacturer Contact: jennifer damato - kls-martin l.p. ; p.o. box 16369; jacksonville, FL 32245 ; 9046417746
• MDR Report Key: 4296650
• MDR Text Key: 20074087
• Report Number: 9610905-2014-00028
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070169
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 24-009-14-71
• Device Lot Number: 32740139
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2014
• 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
• Patient Outcome(s): Other
• Patient Age: 51 YR