MAUDE Adverse Event Report: ZIMMER BIOMET SPINE POLYAXIAL OPEN ILIAC SCREW, DIAMETER 8.5MM X 90MM; VITALITY SPINAL FIXATION SYSTEM

Catalog Number 07.02050.168

Device Problem Disassembly (1168)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

It was reported that the tulip head detachment was noticed on (b)(6) 2017 and revised on (b)(6) 2017.The date of when the tulip head detached from the screw shaft is unknown.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 head was found detached from a pedicle screw shaft, post-operatively.A revision surgery was performed to remove the screw and replace it with a larger diameter screw.No other patient impact was reported.

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.

Manufacturer Narrative

The returned screw was evaluated.The tulip head was confirmed to have dissociated from the screw shaft.The cause is unknown.A review of the manufacturing records did not identify any issues which would have contributed to this event.

• Brand Name: POLYAXIAL OPEN ILIAC SCREW, DIAMETER 8.5MM X 90MM
• 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: 6512393
• MDR Text Key: 73395482
• Report Number: 3004485144-2017-00170
• 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,Followup
• Report Date: 09/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07.02050.168
• Device Lot Number: P141250
• Other Device ID Number: (01)00889024009608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2017
• Initial Date FDA Received: 04/21/2017
• Supplement Dates Manufacturer Received: Not provided; 09/05/2017
• Supplement Dates FDA Received: 06/12/2017; 09/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2015
• 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): Hospitalization; Required Intervention