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

Model Number N/A

Device Problem Bent (1059)

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

Event Date 10/06/2016

Event Type  Injury  

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

It was reported that a set screw was bent.It was removed from the patient during the same procedure and replaced with another device.

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.

• 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; 310 interlocken parkway; suite 120; broomfield CO 80021
• Manufacturer (Section G): ZIMMER BIOMET SPINE; 310 interlocken parkway; suite 120; broomfield CO 80021
• Manufacturer Contact: teresa george ; 310 interlocken parkway; suite 120; broomfield, CO 80021 ; 3034437500
• MDR Report Key: 6074232
• MDR Text Key: 59008892
• Report Number: 3004485144-2016-00297
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• 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,Followup
• Report Date: 06/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2016
• 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: 7703-1600
• Device Lot Number: TC59395
• Other Device ID Number: 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: 05/25/2017
• 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