MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. SCREW, UNKNOWN TYPE; NEXTGEN ALTIUS OCT SYSTEM

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 12/21/2018

Event Type  Injury  

Manufacturer Narrative

Udi number: ni.This device is associated with the lineum product line, but further information is not available.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 the surgeon attempted to remove a previously-implanted device during a trauma case.However, the necessary instrument was not available so the device was unable to be removed.Further information is not available.

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 the surgeon attempted to remove a previously-implanted screw during a trauma case.However, the necessary instrument was not available so the screw was unable to be removed.Further information is not available.

Manufacturer Narrative

Additional information: results and conclusions - the screw was not returned for evaluation, so no results are available and no conclusions can be drawn.The dhr is unable to be reviewed since the lot number was not provided.

Event Description

It was reported that the surgeon attempted to remove a previously-implanted device during a trauma case.However, the necessary instrument was not available so the device was unable to be removed.Further information is not available.

• Brand Name: SCREW, UNKNOWN TYPE
• Type of Device: NEXTGEN ALTIUS OCT 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: 8256932
• MDR Text Key: 133528467
• Report Number: 3012447612-2019-00022
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/14/2019
• 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