MAUDE Adverse Event Report: ZIMMER BIOMET SPINE CANN POLY DUAL LEAD PED SCR TI 6.5X45MM; LANX SPINAL FIXATION SYSTEM

Catalog Number 7740-6545

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/06/2016

Event Type  malfunction  

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.Reference report 3004485144-2016-00399.

Event Description

It was reported that the tips of two pedicle screws became bent during surgery.They were removed and replaced with alternative screws.There are no reports of patient injury associated with this event.This is report one of two for this event.

Manufacturer Narrative

The returned screw was examined.The distal tip of the cannula is flared outwards in a manner consistent with the screw rubbing against the k-wire during installation (k-wire should be removed prior to screw installation into the vertebral body).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, including installation.

• Brand Name: CANN POLY DUAL LEAD PED SCR TI 6.5X45MM
• Type of Device: LANX 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: geoffrey gannon ; 310 interlocken parkway; suite 120; broomfield, CO 80021 ; 3034437500
• MDR Report Key: 6195946
• MDR Text Key: 63075621
• Report Number: 3004485144-2016-00398
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK120399
• 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: 12/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7740-6545
• Device Lot Number: JP00865
• Other Device ID Number: (01)00888480545286
• 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: 08/03/2016
• 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 Age: 52 YR