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

Model Number 24-025-47-09

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 09/03/2015

Event Type  Injury  

Event Description

Following implantation, the sternal plate broke and a secondary surgery was performed in order to remove the broken plate and replace it with a new one.It is the doctor's belief that the patient was not compliant following implantation.

Manufacturer Narrative

The plate was optically assessed and stereoscopically investigated in the lab.The stereo microscopic investigation revealed a tensile crack due to mechanical overload.Further observation determined there were no indications of material or manufacturing defects discovered.Product device history records were also reviewed based on th elot number provided and revealed no abnormalities.The results of the investigation concluded that the root cause for breakage was due to a mechanical overload on the plate.If further information can be gathered that can add value to the contents of the investigated report, an additional follow-up report will be submitted.

• Brand Name: STERNAL PLATE
• Type of Device: BONE FIXATION PLATE
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strabe 10; muhlheim/donau 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: 5114543
• MDR Text Key: 27174085
• Report Number: 9610905-2015-00051
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 09/29/2015

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?: No
• Device Operator: Physician
• Device Model Number: 24-025-47-09
• Device Lot Number: 32813242
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/30/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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