MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. CANNULATED POLYAXIAL SCREW 6.5MM X 50MM; VITALITY SPINAL FIXATION SYSTEM

Catalog Number 824M6550

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

D10: 824m6550, lot unknown, qty 3, vital mis screw; 07.02010.001, lot unknown, qty 3, closure top; 815m1050, lot unknown, qty 2, percutaneous rod; 14-533173, lot unknown, qty 1 zyston curved spacer.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 report 3012447612-2024-00031.

Event Description

It was reported that at the patient's initial post-op appointment, the x-rays revealed the closure top on the right l4 screw had migrated out of its mating screw.There are no patient impacts and a revision surgery is not scheduled at this time.This is report two of two for this event.

Event Description

It was reported that at the patient's initial post-op appointment, the x-rays revealed the closure top on the left l4 screw had migrated out of its mating screw.The surgeon performed a revision surgery specifically to revise the left side of l4 tlif, extracting the migrated vital mis set screw from left l4.During the revision, the closure top was removed and replaced and the screw was removed and replaced with a larger diameter screw.This is report two of two for this event.

Manufacturer Narrative

Corrections in b1, b5, d4: lot number, d9, h1, h3, and h6: impact code.Additional information in b2, b6, d4: udi number, d6b, and h4.Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.

• Brand Name: CANNULATED POLYAXIAL SCREW 6.5MM X 50MM
• 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: 18730874
• MDR Text Key: 336751269
• Report Number: 3012447612-2024-00032
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 0088786851348
• UDI-Public: (01)0088786851348(10)SBM141999
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150896
• 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,Followup
• Report Date: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 824M6550
• Device Lot Number: SBM141999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2022
• 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
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic