MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. CURVE VARIABLE INSERTER; ZYSTON ARC INTERBODY SPACER

Catalog Number 14-533021

Device Problem Material Disintegration (1177)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.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 report number 3012447612-2018-00201.The subject inserter and shaft were used in three procedures within the same hospital with the same outcome prior to manufacturer notification.The inserter is the subject of reports 3012447612-2018-00152, 3012447612-2018-00198, and 3012447612-2018-00200.The shaft is the subject of reports 3012447612-2018-00153, 3012447612-2018-00199, and 3012447612-2018-00201.

Event Description

It was reported that it appeared that metal debris was generated as the surgeon was using a mallet to impact the inserter sleeve and shaft to install an implant into the disc space.The surgeon felt that it is possible that the patient may have retained some of the debris.The sleeve and shaft were used to complete the procedure without additional reported patient impacts.This is report one of two for this event.

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.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.

Manufacturer Narrative

The returned handle was evaluated.There were no indications of material which had separated from the device.A functional evaluation found that the handle operated as expected and no failures were found.A review of the manufacturing records did not identify any issues which would have contributed to this event.

• Brand Name: CURVE VARIABLE INSERTER
• 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: geoffrey gannon ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3034437500
• MDR Report Key: 7282381
• MDR Text Key: 100430680
• Report Number: 3012447612-2018-00200
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: PK110650
• 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: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 14-533021
• Device Lot Number: 310651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other