MAUDE Adverse Event Report: ZIMMER BIOMET SPINE SEQ POLY SCREW ASSY 5.5 X 40; SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM

Model Number N/A

Device Problem Disassembly (1168)

Patient Problem No Consequences Or Impact To Patient (2199)

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 the tulip separated from the screw shaft during a procedure.It was removed from the patient and replaced.There were no reports of patient injury or surgical delay associated with this event.

Manufacturer Narrative

The device was not returned for evaluation.A review of the manufacturing records did not identify any issues which would have contributed to this event.

• Brand Name: SEQ POLY SCREW ASSY 5.5 X 40
• Type of Device: SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR 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: 6167586
• MDR Text Key: 62331521
• Report Number: 3004485144-2016-00359
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK131980
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 3306-5540
• Device Lot Number: 85JP
• Other Device ID Number: (01)00889024334953
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2015
• 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