MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. SCREW+SS 6.0MMX30MM; THE TETHER - VERTEBRAL BODY TETHERING SYSTEM

Catalog Number 211H6030

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cerebrospinal Fluid Leakage (1772); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Type of the device: device product code: qhp 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 3012447612-2020-00345 to 3012447612-2020-00359.

Event Description

It was reported that a patient presented in the emergency room with a pleural effusion related to a csf leak after a tether procedure.The patient underwent a revision surgery to drain the spinal fluid.There was no further information provided.This is report fourteen of fifteen for this event.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).D11 - medical product: catalog #: 211h6032, 6.0mm dia x 32.5mm vbt assy, lot # unknown.Catalog #: 204h0300, 300mm vbt cord, lot # unknown.Catalog #: 211h6535, 6.5mm dia x 35mm vbt assy, lot # unknown.Catalog #: 211h6035, 6.0mm dia x 35mm vbt assy, lot # unknown.Catalog #: 211h6035, 6.0mm dia x 35mm vbt assy, lot # unknown.Catalog #: 211h6035, 6.0mm dia x 35mm vbt assy, lot # unknown.Catalog #: 203h0012, 12mm vbt anchor, lot # unknown.Catalog #: 203h0012, 12mm vbt anchor, lot # unknown.Catalog #: 203h0012, 12mm vbt anchor, lot # unknown.Catalog #: 203h0012, 12mm vbt anchor, lot # unknown.Catalog #: 203h0012, 12mm vbt anchor, lot # unknown.Catalog #: 203h0012, 12mm vbt anchor, lot # unknown.Catalog #: 203h0012, 12mm vbt anchor, lot # unknown.Catalog #: 211h6030, 6.0mm dia x 30mm vbt assy, lot # unknown.Catalog #: 211h6027, 6.0mm dia x 27.5mm vbt assy, lot # unknown.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.A definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.H3 other text : remains implanted.

• Brand Name: SCREW+SS 6.0MMX30MM
• Type of Device: THE TETHER - VERTEBRAL BODY TETHERING SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 10305174
• MDR Text Key: 199834556
• Report Number: 3012447612-2020-00358
• Device Sequence Number: 1
• Product Code: QHP
• Combination Product (y/n): N
• PMA/PMN Number: H190005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 211H6030
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Other; Required Intervention