MAUDE Adverse Event Report: ZIMMER SPINE VIRAGE, TOWER ROD REDUCER

Model Number N/A

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/28/2016

Event Type  malfunction  

Manufacturer Narrative

Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.

Event Description

The sales associate reported broken tower reducers.The tower reducers broke intra-operatively, a posterior cervical procedure.The surgery was completed.

Manufacturer Narrative

The returned towers were examined.The tips were fractured; the complaint is confirmed.A review of the manufacturing records did not identify any issues which would have contributed to this event.An incremental design enhancement has been made, subsequent to the manufacture of the devices associated with this event, to add strength to the tip to reduce breakage.The surgery was completed and no foreign bodies fell into the patient.There was no report of patient injury or adverse event.

• Brand Name: VIRAGE, TOWER ROD REDUCER
• Type of Device: TOWER ROD REDUCER
• Manufacturer (Section D): ZIMMER SPINE; 7375 bush lake road; minneapolis MN 55439
• Manufacturer (Section G): ZIMMER SPINE; 7375 bush lake road; minneapolis MN 55439
• Manufacturer Contact: michelle cole ; 7375 bush lake road; minneapolis, MN 55439 ; 9528325600
• MDR Report Key: 5922041
• MDR Text Key: 53726623
• Report Number: 0002184052-2016-00199
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK133556
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 07.01776.001
• Device Lot Number: 63065354
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2015
• Is the Device Single Use?: No
• 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): Required Intervention