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

Model Number N/A

Device Problem Migration (4003)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Unspecified Vascular Problem (4441)

Event Date 02/08/2021

Event Type  Injury  

Manufacturer Narrative

Summary: the complaint is unrefuted for unreturned vital scerw (pn: unk) for the failure of screw fractured post.The product was not returned, and no photos were provided.Medical records were not provided for review.Potential cause: since the products were not returned, and no photos or x-rays were provided.Root cause can't be established.It is possible that the fractures and migration occurred when the patient heard the pop as they tried to stand up.Dhr review and related actions: lot numbers were not provided, dhr review can't be preformed.No actions required.This event is not related to any current actions or recalls or product holds.Device use and compatibility: this devices are used for treatment.Reported event is not related to a combination of product lines; therefore a compatibility review is not applicable.A follow-up report will be submitted if new information is received that changes the information provided in this report.Reference reports 3012447612-2021-00082 to 3012447612-2021-00087.

Event Description

It was reported that a revision surgery was performed after l2 screws pushed through and fractured pedicles and an infix at l2-3 had anterior migration.This occurred after the patient rocked forwards and backwards to push himself out of his seat independently, and heard a pop and felt pain.During revision surgery, the infix device was removed, and a vascular injury while closing the anterior portion prevented the surgeon from performing the posterior portion of the surgery.The patient was placed in the icu and remained there as of (b)(6) 2021.This is report one of six for this event.

• Brand Name: POLYAXIAL SCREW, UNKNOWN SIZE
• Type of Device: VITALITY 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: kim martinez ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 11475395
• MDR Text Key: 239511086
• Report Number: 3012447612-2021-00082
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171907
• 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
• Report Date: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 701MXXXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/16/2021
• 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: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Weight: 137