MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. MPF SPACER PEEK 15DEG 18X55X10; BIOMET FUSION SYSTEM

Catalog Number 8622-5510

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Code Available (3191)

Event Date 11/08/2017

Event Type  Injury  

Manufacturer Narrative

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 was found to have migrated ipsilaterally one day post-op when the surgeon was performing a posterior procedure for additional fixation.The spacer was installed without the corresponding mating plate and screws.The surgeon was not able to successfully reposition the spacer and continued on with the posterior fixation to complete the procedure.Information regarding further patient impacts has been requested but not provided.

Manufacturer Narrative

The product was not returned and no photos were provided, so an evaluation is unable to be performed.As such, no evaluation results are available and no conclusions regarding the cause can be drawn.The lot number was not provided, so the dhr is unable to be reviewed.The labeling was reviewed and provides instructions notifying the user that a plate and screw(s) are required for any implants with 14 degree or greater lordosis; the implant used has 15 degrees of lordosis and the plate and screw were not used.It also states that the risk of a device expulsion and migration is higher without the use of integrated fixation screws or supplemental fixation.

• Brand Name: MPF SPACER PEEK 15DEG 18X55X10
• Type of Device: BIOMET FUSION 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: geoffrey gannon ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3034437500
• MDR Report Key: 7125198
• MDR Text Key: 95170957
• Report Number: 3012447612-2017-00690
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK163543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8622-5510
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2018
• 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): Other