MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. PEDICLE SCREW, UNKNOWN TYPE OR SIZE; VITALITY SPINAL FIXATION SYSTEM

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Phone number: (b)(6); the software would not allow the phone number to be entered.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 a closure top back backed out of a pedicle screw post-operatively.No further information has been provided.This is report two of two for this event.

Manufacturer Narrative

The complaint is unrefuted for unreturned vitality screw (pn: unk) for the failure of screw backed out postoperation.The products were not returned, and no photos were provided.Medical records were not provided for review.Potential cause: root cause can't be established, since the products were not returned.Dhr review and related actions: lot numbers were not provided, therefore dhr review can't be reviewed.A follow-up report will be submitted if new information is received that changes the information provided in this report.Reference report 3012447612-2020-00613-1.

Event Description

It was reported a closure top backed out of a pedicle screw post-operatively.No further information has been provided.This is report two of two for this event.

• Brand Name: PEDICLE SCREW, UNKNOWN TYPE OR SIZE
• Type of Device: VITALITY SPINAL FIXATION SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 10681134
• MDR Text Key: 213698529
• Report Number: 3012447612-2020-00614
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K150896
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/16/2020
• Initial Date FDA Received: 10/14/2020
• Supplement Dates Manufacturer Received: 02/17/2021
• Supplement Dates FDA Received: 03/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1