MAUDE Adverse Event Report: ZIMMER BIOMET SPINE - BROOMFIELD OGEN MESH CATHRODE/DETACHABLE; IMPLANTABLE BONE STIMULATOR

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 03/23/2016

Event Type  Injury  

Manufacturer Narrative

The device evaluation is anticipated, a follow up report will be sent upon completion of the product evaluation.

Event Description

The facility lab reported patient had bone stimulator explanted due to infection.Patient previously had wound complications from right ankle arthrodesis.She has a 3 year(s) history of right ankle pain and wound healing problems including infection for right ankle arthrodesis.Initial implant surgery performed on (b)(6) 2012.Patient developed infection in wound and chronic draining.Bone stimulator explanted on (b)(6) 2016.After explant, patient given antibiotics and had complex repair of stimulator cavity wound.

Manufacturer Narrative

The unit and cable were received inside biohazard bag.A visual inspection of the returned device identified the unit cathode is broken.The device history records and sterilization records were reviewed and no anomalies were identified.It is reported the unit was implanted on (b)(6) 2012 and the implant stimulator should deliver its full rated current for approximately twenty-four (24) weeks; therefore the unit completed treatment two years ago.No physical and/or functional condition could be found that could be considered as causal factor for the reported complaint.The reported claim is most likely due to the clinical condition of the patient.

• Brand Name: OGEN MESH CATHRODE/DETACHABLE
• Type of Device: IMPLANTABLE BONE STIMULATOR
• Manufacturer (Section D): ZIMMER BIOMET SPINE - BROOMFIELD; 310 interlocken parkway; suite 120; broomfield CO 80021
• Manufacturer (Section G): ZIMMER BIOMET SPINE - BROOMFIELD; 310 interlocken parkway; suite 120; broomfield CO 80021
• Manufacturer Contact: michelle cole ; 310 interlocken parkway; suite 120; broomfield, CO 80021 ; 3034437500
• MDR Report Key: 5676571
• MDR Text Key: 45819649
• Report Number: 3004485144-2016-00087
• Device Sequence Number: 1
• Product Code: LOE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP850035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/26/2016

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/02/2014
• Device Model Number: N/A
• Device Catalogue Number: 10-1320M
• Device Lot Number: 540-12
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/26/2016
• Initial Date FDA Received: 05/24/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR