MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. CURVE SPACER 8MM X 32MM 6DEG PEEK LORDOTIC; ZYSTON ARC INTERBODY SPACER

Catalog Number	14-533168
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, that a revision surgery was performed to address post-operative pain.At a post-op follow up, the patient presented with increasing back and new leg pain.As well as, forward flexion.Studies showed, that one closure top at l2 migrated out of its mating screw, allowing the cage to migrate posteriorly.During the revision, the cage was repositioned and the bilateral screws, closure tops and rods were removed and replaced at l2.This is report three of three for this event.
Additional Manufacturer Narrative
D10: 1x- 701m6545, 2x- 07.02015.013, 2x- 07.02035.001, 1x- 07.02010.001.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 reports (b)(4) through (b)(4).
Additional Manufacturer Narrative
D4: the remainder of the udi number is unknown because the lot number is not available.H6: additional method code: 4110.Additional information in d4: udi number and h6: component, investigation type, findings, and conclusions.Device evaluation: the device was not returned, however x-ray images were provided which show that the spacer has migrated.Root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to instability due to the migration of the associated closure top out of its screw.Dhr review: the lot number was not reported and the device was not returned, therefore a dhr review is unable to be performed.Device usage: this device is used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.
Event or Problem Description
It was reported that a revision surgery was performed to address post-operative pain.At a post-op follow up, the patient presented with increasing back and new leg pain, as well as forward flexion.Studies showed that one closure top at l2 migrated out of its mating screw, allowing the cage to migrate posteriorly.During the revision, the cage was repositioned and the bilateral screws, closure tops, and rods were removed and replaced at l2.This is report three of three for this event.

• Brand Name: CURVE SPACER 8MM X 32MM 6DEG PEEK LORDOTIC
• Common Device Name: ZYSTON ARC INTERBODY SPACER
• 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: teresa george ; 10225 westmoor dr.; westminster, CO 80021 ; 3035018506
• MDR Report Key: 20110970
• Report Number: 3012447612-2024-00240
• Device Sequence Number: 20951018
• Product Code: MAX
• UDI-Device Identifier: 00888480611721
• UDI-Public: (01)00888480611721
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K110650
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2025

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 14-533168
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/30/2024
• Supplement Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic