MAUDE Adverse Event Report: ZIMMER BIOMET SPINE OPEN MULTIAXIAL SCREW, 4.5MM DIA. X 30MM; POLARIS SPINAL SYSTEM

Catalog Number 14-562130

Device Problem Use of Device Problem (1670)

Patient Problem No Code Available (3191)

Event Date 03/14/2017

Event Type  Injury  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.The surgeon stated the issue was caused by user error with the screw cap being forced on, causing it to be slightly off angle and resulting in cross threading.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 screw cap was forced on by the assisting surgeon, causing it to be slightly off angle so it cross threaded.The screw was removed from the patient's body and replaced.There were no further reported consequences to the patient.The main surgeon stated the event was 100% user error.

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 found to have been slightly splayed open and the threads were sheared and deformed, likely the result of cross-threading the plug into the tulip head, as per the events described by the complainant.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 sufficient instructions regarding proper assembly.

• Brand Name: OPEN MULTIAXIAL SCREW, 4.5MM DIA. X 30MM
• Type of Device: POLARIS SPINAL 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: 6482897
• MDR Text Key: 72472047
• Report Number: 3004485144-2017-00144
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK151974
• 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: 08/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 14-562130
• Device Lot Number: 3779322
• Other Device ID Number: (01)00888480597759(10)3779322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR