MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. ADJUSTABLE TRANSVERSE CONNECTOR ASSEMBLIES 33-36 WIDE X 5.5 MM ROD; VITALITY SPINAL FIXATION SYSTEM

Catalog Number 07.02030.001

Device Problem Compatibility Problem (2960)

Patient Problem No Patient Involvement (2645)

Event Date 06/12/2018

Event Type  malfunction  

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 transverse connector would not attach correctly to a mating rod during a product demonstration.A patient was not involved with this event.

Manufacturer Narrative

Udi: na.Additional information: (ethnicity), (methods, results, and conclusions) - the closure top was returned for evaluation.The threads were found to have fractured off.Based on the event description and the nature of the thread failure, it is likely the failure is due to misalignment between the closure top and pedicle screw tulip head.A review of the dhr did not identify any issues which would have contributed to this event.

Event Description

It was reported that a transverse connector would not attach correctly to a mating rod during a product demonstration.A patient was not involved with this event.

• Brand Name: ADJUSTABLE TRANSVERSE CONNECTOR ASSEMBLIES 33-36 WIDE X 5.5 MM ROD
• 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: 7763219
• MDR Text Key: 116539989
• Report Number: 3012447612-2018-00555
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK150896
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 07.02030.001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/09/2018
• 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