MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. SHORT ROCKET REDUCER; VITALITY SPINAL FIXATION SYSTEM

Catalog Number 730M0024

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/26/2023

Event Type  Injury  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.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 foreign object was observed when the surgeon was reviewing an x-ray that was taken intra-operatively.It is believed to be the pin from a rocket reducer, but this cannot be fully determined.There are no plans to revise the patient to remove the object.

• Brand Name: SHORT ROCKET REDUCER
• 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.; westminster CO 80021
• Manufacturer Contact: sabrina abla ; 10225 westmoor dr.; westminster, CO 80021 ; 7206965158
• MDR Report Key: 17398730
• MDR Text Key: 319833972
• Report Number: 3012447612-2023-00225
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00887868244780
• UDI-Public: (01)00887868244780(10)MC4325503B
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183550
• Exemption Number: 5645646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 730M0024
• Device Lot Number: MC4325503B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic