MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. ZYSTON STRAIGHT INLINE INSERTER; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	14-534900
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that both prongs on the tip of a zyston inserter broke off while inserting the cage into the disc space intra-operatively; the connection between the inserter and cage loosened.The threads of the cage were damaged while the surgeon was backing it out to exchange inserters; the cage was also replaced to complete the procedure without patient impacts.
Additional Manufacturer Narrative
D4: the remainder of the udi number is unknown because the lot number is not available.D10: 14-534187 lot 0100371 (zyston straight 7h x 20lx10w lordotic 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.
Additional Manufacturer Narrative
Additional information in h6: investigation type, findings, and conclusions.Device evaluation: the device was not returned and no photos were provided, so an evaluation is unable to be performed.Root cause: this event could possibly be attributed to off-axis or excessive forces applied during use.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 both prongs on the tip of a zyston inserter broke off while inserting the cage into the disc space intra-operatively; the connection between the inserter and cage loosened.The threads of the cage were damaged while the surgeon was backing it out to exchange inserters; the cage was also replaced to complete the procedure without patient impacts.

• Brand Name: ZYSTON STRAIGHT INLINE INSERTER
• 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: 22328378
• Report Number: 3012447612-2025-00248
• Device Sequence Number: 9582625
• Product Code: MAX
• UDI-Device Identifier: 00888480472100
• UDI-Public: (01)00888480472100
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K112014
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 09/30/2025

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: 14-534900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 10/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic