MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. CURVE SPACER 8MM X 32MM 6DEG PEEK LORDOTIC; ZYSTON ARC INTERBODY SPACER

Catalog Number 14-533168

Device Problem Migration (4003)

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

Event Type  Injury  

Manufacturer Narrative

The initial and revision surgeries were performed in (b)(6) 2018.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 spacer migrated three days post-operatively and caused pain.A revision surgery was performed to remove the spacer and replace it with a larger spacer.

Manufacturer Narrative

The device was not returned for evaluation.However, photos of x-rays were provided.The images confirmed the spacer backed out of the disc space post-operatively.Photos showing the initial placement of the spacer were not available.Therefore, the root cause cannot be conclusively determined.

Event Description

It was reported that a spacer migrated three days post-operatively and caused pain.A revision surgery was performed to remove the spacer and replace it with a larger spacer.

• Brand Name: CURVE SPACER 8MM X 32MM 6DEG PEEK LORDOTIC
• Type of Device: ZYSTON ARC INTERBODY SPACER
• 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: 8053552
• MDR Text Key: 126628613
• Report Number: 3012447612-2018-00887
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K110650
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 14-533168
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/10/2018
• Initial Date FDA Received: 11/08/2018
• Supplement Dates Manufacturer Received: 11/19/2018
• Supplement Dates FDA Received: 12/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 39 YR