MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. CORD 300MM; THE TETHER- VERTEBRAL BODY TETHERING SYSTEM

Catalog Number 204H0300

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

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Type of the 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.

Event Description

It was reported that a patient will need a revision surgery after the their curve began to increase 3 months postoperatively.A revision is planned, to remove and retighten the cord, but not scheduled at this time.No further patient or surgical information has been provided.

Event Description

It was reported that a patient will need a revision surgery after the their curve began to increase 3 months postoperatively.A revision is planned, to remove and retighten the cord, but not scheduled at this time.No further patient or surgical information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.A2: date of birth: unknown day in (b)(6) of 2007 a4: weight: 33.8 kg d4: udi#: (b)(4).D11: catalog#: 211h6035 6.0mm dia x 35mm vbt assy, lot#: ni.Catalog#: 211h6032 6.0mm dia x 32.5mm vbt assy, lot#: 2958624.Catalog#: 302h0012, lot#: 2958624.Catalog#: 211h6030 6.0mm dia x 30mm vbt assy, lot#: 2958623.Catalog#: 211h6025 6.0mm dia x 25mm vbt assy, lot#: 2970357.Catalog#: 211h6027 6.0mm dia x 27.5mm vbt assy, lot#: 2958622.The event is confirmed with x-rays received.Visual examination of the x-rays confirmed that the curve of the patient's spine had exceeded 38 degrees post-op.Dhr was reviewed and no discrepancies relevant to the reported event were found.Following the initial surgery, patient condition should have stabilized or improved.Although there is no clear defect with the part, the patient's condition did not appear to improve.Root cause was unable to 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.

Event Description

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

• Brand Name: CORD 300MM
• 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: 10600291
• MDR Text Key: 209003199
• Report Number: 3012447612-2020-00574
• 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,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 204H0300
• Device Lot Number: 2966796
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 12 YR
• Patient Weight: 33