MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. CURVE SPACER 7MM X 27MM 6DEG PEEK LORDOTIC; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	14-533127
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while inserting the zyston cage at t11/12 during a posterolateral lumbar fusion, the peek chipped.The fragment was removed but the cage remained implanted and the surgery was completed without any patient harm or delays.
Additional Manufacturer Narrative
There is both an implant date and a return to manufacturer date since the majority of the implant remains implanted and a small fragment was returned.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.
Additional Manufacturer Narrative
H3: "device evaluation anticipated, but not yet begun" is erroneous and no longer applies.The device was evaluated.Corrections in h3.Additional information in h6: investigation type, findings, and conclusions.A review of the dhr was conducted and found no indications of manufacturing issues.The full device was not returned but a fragment of peek from the device was returned along with photos.This event likely cannot be attributed to manufacturing or design related issues.The complaint is confirmed for zyston spacer for the failure of fracture.The failure could possibly be attributed to excessive forces being applied beyond intended use.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 while inserting the zyston cage at t11/12 during a posterolateral lumbar fusion, the peek chipped.The fragment was removed but the cage remained implanted and the surgery was completed without any patient harm or delays.

• Brand Name: CURVE SPACER 7MM X 27MM 6DEG PEEK LORDOTIC
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• 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: 23868296
• Report Number: 3012447612-2025-00397
• Device Sequence Number: 4438071
• Product Code: MAX
• UDI-Device Identifier: 03662663155205
• UDI-Public: (01)03662663155205(17)350214(10)105471
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K110650
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 14-533127
• Device Lot Number: 105471
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/18/2025
• 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: 12/22/2025
• Supplement Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2025
• 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
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic