MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. REDUCTION MULTI-AXIAL SCREW 5.5MM(D)X30MM(L) EXT.; SYNERGY TI ANTERIOR SPINAL SYSTEM

Catalog Number 53-6105MP

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Unspecified Infection (1930); No Code Available (3191)

Event Date 10/11/2013

Event Type  Injury  

Manufacturer Narrative

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.Reference reports 3004485144-2016-00007 thru 3004485144-2016-00010, 3012447612-2017-00154 thru 3012447612-2017-00157, and voluntary report mw5068372.

Event Description

It was reported that a revision surgery was performed to address pseudoarthrosis at levels t12-l1 and l2-l3.Information from voluntary medwatch mw5068372 states that the revision also addressed cap screws which were not tight, followed by screws which were loose, followed by broken rod, and an infection.This is report five of eight for this event.

• Brand Name: REDUCTION MULTI-AXIAL SCREW 5.5MM(D)X30MM(L) EXT.
• Type of Device: SYNERGY TI ANTERIOR SPINAL 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: geoffrey gannon ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3034437500
• MDR Report Key: 6600001
• MDR Text Key: 76233596
• Report Number: 3012447612-2017-00154
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK950709
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 53-6105MP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/20/2017
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 22 YR