MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. SET SCREW 5.5MM ROD TI; MODIFICATION TO LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM

Catalog Number 7703-1600

Device Problem Bent (1059)

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

Event Date 10/06/2016

Event Type  Injury  

Manufacturer Narrative

The returned set screw was examined.There are indications that the set screws were installed, locked into place, and then removed.However, there was no damage to the thread form and the witness marks indicate the set screw was secured appropriately against the rod.No indications of malfunctions were detected.It is possible the set screw was removed for some type of adjustment to the construct and the surgeon replaced them as prescribed by the device labeling.A review of the manufacturing records did not identify any issues which would have contributed to this event.The labeling was reviewed and found to contain instructions regarding proper device usage.Reference reports 3004485144-2016-00297, 3004485144-2016-00300, and 3012447612-2017-00212.

Event Description

It was reported that four set screws were bent during surgery.They were removed from the patient during the same procedure and replaced with alternative devices.There were no reports of patient injury associated with this event.This is report four of four for this event.

• Brand Name: SET SCREW 5.5MM ROD TI
• Type of Device: MODIFICATION TO LANX POSTERIOR CERVICOTHORACIC 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: geoffrey gannon ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3034437500
• MDR Report Key: 6656855
• MDR Text Key: 78060651
• Report Number: 3012447612-2017-00213
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK100888
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7703-1600
• Device Lot Number: TC59395
• Other Device ID Number: (01)00888480530022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2016
• 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): Required Intervention
• Patient Age: 52 YR