MAUDE Adverse Event Report: ZIMMER BIOMET SPINE BOTTOM LOADING POLY OPEN ILIAC SCREW ASSEMBLIES 7.5X70; VITALITY SPINAL FIXATION SYSTEM

Catalog Number 07.02050.122

Device Problem Disassembly (1168)

Patient Problem No Code Available (3191)

Event Date 01/18/2017

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 pedicle screw disassembled during surgery.The set screw and rod were being tightened down into the tulip when the tulip detached from the screw shaft.The screw was removed and replaced with a larger screw.There were no reports of patient injury associated with this event.

Manufacturer Narrative

The returned screw was evaluated.It was returned fully assembled in one piece.Further communication with the complainant revealed that the screw was reassembled after the event.The screw was not able to be disassembled so the complaint could not be confirmed as the reported condition could not be replicated.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: BOTTOM LOADING POLY OPEN ILIAC SCREW ASSEMBLIES 7.5X70
• Type of Device: VITALITY 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: 6348876
• MDR Text Key: 67944026
• Report Number: 3004485144-2017-00082
• 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: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07.02050.122
• Device Lot Number: P141242
• Other Device ID Number: (01)00889024009523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2015
• 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): Other