MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. 6.5 X 45MM MULTIAXIAL REDUCTION SCREW; EBI 5.5 HELICAL FLANGE SPINAL SYSTEM

Catalog Number 2000-7445

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem No Code Available (3191)

Event Date 09/25/2018

Event Type  Injury  

Manufacturer Narrative

Udi number: ni.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.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.Reference reports 3012447612-2018-00861 thru 3012447612-2018-00871.

Event Description

It was reported that two screws were found to have disassembled and one plug had migrated out of a third screw post-operatively.A revision surgery was performed to remove and replace the screws and plug.During the revision, eight plugs were found to have loosened from their mating pedicle screws.These plugs were also removed and replaced.This is report twelve of twelve for this event.

Manufacturer Narrative

Additional information: catalog number and lot number; 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.

Event Description

It was reported that two screws were found to have disassembled and one plug had migrated out of a third screw post-operatively.A revision surgery was performed to remove and replace the screws and plug.During the revision, eight plugs were found to have loosened from their mating pedicle screws.These plugs were also removed and replaced.This is report twelve of twelve for this event.

Manufacturer Narrative

Udi number: na.Additional information: method, results and conclusion - the returned screw was examined.The tulip head has disassembled from the screw shank.The complaint is confirmed.Abnormal wear found within the saddle of the tulip head was likely a result of a loose rod moving inside of the saddle post-operatively.This was likely caused by inadequate reduction of the rod by the plug.The loose rod likely put increased stresses on the screw and caused disassembly to occur.Additionally, the patient's scoliosis may have contributed to the inadequate plug positioning as this would likely have made the procedure more difficult.There were no manufacturing issues detected which would have contributed to this event.

Event Description

It was reported that two screws were found to have disassembled and one plug had migrated out of a third screw post-operatively.A revision surgery was performed to remove and replace the screws and plug.During the revision, eight plugs were found to have loosened from their mating pedicle screws.These plugs were also removed and replaced.This is report twelve of twelve for this event.

• Brand Name: 6.5 X 45MM MULTIAXIAL REDUCTION 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: ashley mcpherson ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3034437500
• MDR Report Key: 8022575
• MDR Text Key: 125590172
• Report Number: 3012447612-2018-00872
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K061441
• 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,Followup
• Report Date: 03/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2000-7445
• Device Lot Number: 2188902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2009
• 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: 17 YR