MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. 6.5 X 50MM MULTIAXIAL SCREW; EBI 5.5 HELICAL FLANGE SPINAL SYSTEM

Catalog Number 2000-2450

Device Problems Break (1069); Disassembly (1168)

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

Event Date 05/22/2017

Event Type  malfunction  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.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.

Event Description

It was reported that a pedicle screw disassembled as a result of the security ring breaking within surgery during installation.The screw was replaced with an alternative screw of the same size.There were no reports of patient injury associated with this event.

Manufacturer Narrative

Additional information: the returned screw was evaluated.The tulip and cap ring were disassembled from the remainder of the screw assembly.The deformation to the individual subcomponents suggests that an aggressive angle was placed on the screw during installation which caused the subcomponents to deform and disassemble.A review of the manufacturing records did not identify any issues which would have contributed to this event.

• Brand Name: 6.5 X 50MM MULTIAXIAL SCREW
• Type of Device: EBI 5.5 HELICAL FLANGE 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: 6646770
• MDR Text Key: 77765936
• Report Number: 3012447612-2017-00214
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PK061441
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2000-2450
• Device Lot Number: J38884730
• Other Device ID Number: (01)00888480207764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2016
• 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