MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. PEDICLE SCREW TI 5.5X40MM; SPINAL FIXATION SYSTEM

Catalog Number 7715-5540

Device Problem Biocompatibility (2886)

Patient Problem Reaction (2414)

Event Date 10/26/2018

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.Reference reports 3012447612-2018-00942 thru 3012447612-2018-00952.

Event Description

It was reported that a patient developed an allergic reaction about 6-8 months post-operatively.The surgeon believes it may possibly be related to the implants.A course of action for treatment has not yet been decided upon.This is report eight of eleven for this event.

Manufacturer Narrative

Additional information: results and conclusions - the device was not returned for evaluation so no results are available and no conclusions can be drawn.The manufacturing records were unable to be reviewed since the lot number is unknown.Allergic reaction to the implant material is a known possible complication associated with the device per its labeling.

Event Description

It was reported that a patient developed an allergic reaction about 6-8 months post-operatively.The surgeon believes it may possibly be related to the implants.A course of action for treatment has not yet been decided upon.This is report eight of eleven for this event.

• Brand Name: PEDICLE SCREW TI 5.5X40MM
• Type of Device: SPINAL FIXATION 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: ashley mcpherson ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3034437500
• MDR Report Key: 8108296
• MDR Text Key: 128558722
• Report Number: 3012447612-2018-00949
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092536
• 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: 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7715-5540
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/27/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 109