MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. POLYAXIAL SCREW ASSEMBLY 6.5 X 50MM; SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM

Catalog Number 3306-6550

Device Problem Disassembly (1168)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 06/28/2017

Event Type  Injury  

Manufacturer Narrative

The returned screw was evaluated and found to be disassembled.The splines on the screw shaft were found to be deformed in a manner consistent with tightening of the rod and closure top with the screw.The tulip loosening from the shaft prior to the revision could have been cause by the repetitive loading and bending associated with the patient's activities which allowed the shaft to move slightly within the housing, and then once loosened, allowed the tulip and retention ring to fully disassemble from the shaft during removal.A review of the manufacturing records did not identify any issues which may have contributed to this event.The labeling was reviewed and found to contain post-operative expectations and warnings.

Event Description

It was reported that the tulip of a pedicle screw started to loosen from the screw shaft post-operatively and then the tulip completely disassembled from the shaft during removal.A revision surgery was performed to remove and replace the screw.The patient reported they had returned to running and cycling as part of his normal activities post-surgery.

• Brand Name: POLYAXIAL SCREW ASSEMBLY 6.5 X 50MM
• Type of Device: SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR 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: 7231182
• MDR Text Key: 98678436
• Report Number: 3012447612-2018-00088
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK131980
• 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
• Report Date: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3306-6550
• Device Lot Number: 84MF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2015
• 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
• Patient Age: 63 YR