MAUDE Adverse Event Report: BIOMET MICROFIXATION LORENZ STERNAL CLOSURE SYSTEM; PLATE 4 HOLE L 100 DEG

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Aspiration/Inhalation (1725); Bacterial Infection (1735); Death (1802); Fall (1848); Renal Failure (2041); Respiratory Failure (2484)

Event Date 07/04/2016

Event Type  Injury  

Manufacturer Narrative

Review of device history records show the lot released with no recorded anomaly or deviation.The user facility is foreign; therefore a facility medwatch report will not be available.It is reported the facility disposed of the explanted devices.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Report two of five for the same event, reference 1032347-2016-00415 through 1032347-2016-00419.

Event Description

It is reported the original procedure, a coronary artery bypass, occurred (b)(6) 2016.The patient fell on (b)(6) 2016 and the plate deviation was confirmed by x-ray.On (b)(6) 2016 acute renal failure and mediastinitis appeared, it was confirmed mrsa was present.On (b)(6) 2016 debridement for the mediastinitis and (revision) removal of the plate and grafting of part of the peritoneum were conducted.The patient passed away on (b)(6) 2016.The cause of death listed on the death certificate is acute respiratory insufficiency and aspiration pneumonia.

• Brand Name: LORENZ STERNAL CLOSURE SYSTEM
• Type of Device: PLATE 4 HOLE L 100 DEG
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: michelle cole ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 5886034
• MDR Text Key: 52425338
• Report Number: 0001032347-2016-00416
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK011076
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 73-2643
• Device Lot Number: J178100
• Other Device ID Number: (01)00841036141042(10)J178100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention