MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. DIA. 5.5 STRAIGHT RODS, TI ALLOY 300MM; VITALITY SPINAL FIXATION SYSTEM

Catalog Number 07.02013.001

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Udi number: ni.Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.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.

Event Description

It was reported that a rod was found broken during a 6 week post-operative check-up.The patient described hearing a snap while reaching for something and subsequent imaging showed the left rod to be broken above l4.Additional information has been requested, but has not been provided.

Manufacturer Narrative

Additional information: methods, results and conclusions - the device was not returned, however, photos of x-rays were provided capturing the rod fractured above the l4 screw.The cause cannot be conclusively determined with the available information.The production records could not be reviewed as the lot number was not provided.

Event Description

It was reported that a rod was found broken during a 6 week post-operative check-up.The patient described hearing a snap while reaching for something and subsequent imaging showed the left rod to be broken above l4.Additional information has been requested, but has not been provided.

• Brand Name: DIA. 5.5 STRAIGHT RODS, TI ALLOY 300MM
• Type of Device: VITALITY SPINAL FIXATION SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer (Section G): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; na; westminster CO 80021
• Manufacturer Contact: ashley mcpherson ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3034437500
• MDR Report Key: 8541615
• MDR Text Key: 142813073
• Report Number: 3012447612-2019-00189
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150896
• 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: 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07.02013.001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/06/2019
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 106