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

Model Number 24-009-11-71

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Adhesion(s) (1695); Hemorrhage/Bleeding (1888); Unspecified Infection (1930)

Event Date 10/14/2015

Event Type  Injury  

Event Description

Following implantation, patient returned to the hospital for an infection in the lower sternum, and was placed on a wound vac.When the wound vac was removed, there was an accumulation of blood under the vac.Patient was taken to the or.The underlying structures had adhered to the posterior table of the sternum.The implants were removed, the repair was made and the patient was re-plated and later discharged.

Manufacturer Narrative

An investigation was performed on the basis of complaint statistics as no device was sent back for evaluation.It is determined that the complaint percentage falls well within the product risk limits that are adhered to at klm.The material and device history records were also reviewed based on the lot number provided and revealed no abnormalities.Due to no physical device available for evaluation, the reported incident cannot be appropriately validated and the root cause cannot be determined.If further information can be gathered that might add value to the contents of the investigated report, an additional follow-up report will be submitted.

• Brand Name: STERNAL TALON
• Type of Device: STERNAL FIXATION DEVICE
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; karl leibinger medizintechnik; muhlheim/donau 78570 ; GM 78570
• Manufacturer (Section G): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strabe 10; muhlheim/donau, 78570 ; GM 78570
• Manufacturer Contact: jennifer damato ; p.o. box 16369; jacksonville, FL 32245 ; 9046417746
• MDR Report Key: 5238892
• MDR Text Key: 31698783
• Report Number: 9610905-2015-00062
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 24-009-11-71
• Device Lot Number: 31419221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/22/2015
• 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
• Patient Outcome(s): Other
• Patient Age: 38 YR