MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. CURVE SPACER 8MM X 27MM 6DEG PEEK LORDOTIC; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	14-533128
Medical Device Problem Codes	Fracture (1260); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a zyston curve spacer fractured in the disc space intra-operatively.The doctor felt that the inserter connecting with the cage was loose, and he decided to pull it out and replace the cage.During the removal process, he discovered that the cage was broken.The cracked peek was removed as much as possible, however it is possible that a small amount remained in the patient body.The implant was removed and replaced with a new implant of the same size using the same inserter, so it is unlikely there was an issue with the inserter.There was only a five minute procedural delay and otherwise no patient harm.
Additional Manufacturer Narrative
D4: the remainder of the udi number is unknown because the lot number is not available.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
Corrections in d4: lot number & udi number, d9, and h3.Additional information in d4: expiration date and h4.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 zyston curve spacer fractured in the disc space intra-operatively.The doctor felt that the inserter connecting with the cage was loose, and he decided to pull it out and replace the cage.During the removal process, he discovered that the cage was broken.The cracked peek was removed as much as possible, however it is possible that a small amount remained in the patient body.The implant was removed and replaced with a new implant of the same size using the same inserter, so it is unlikely there was an issue with the inserter.There was only a five minute procedural delay and otherwise no patient harm.
Event or Problem Description
It was reported that a zyston curve spacer fractured in the disc space intra-operatively.The doctor felt that the inserter connecting with the cage was loose, and he decided to pull it out and replace the cage.During the removal process, he discovered that the cage was broken.The cracked peek was removed as much as possible, however it is possible that a small amount remained in the patient body.The implant was removed and replaced with a new implant of the same size using the same inserter, so it is unlikely there was an issue with the inserter.There was only a five minute procedural delay and otherwise no patient harm.
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.Device evaluation: the returned device matches the information in the complaint file and was examined.Visual inspection revealed the implant is fractured.A functional inspection was performed with an inserter (14-533021) and the threaded rod (14-533041) and found the rod/inserter was able to thread to the insert from the implant as expected.It was reported that the cracked peek was removed as much as possible, however it is possible that a small amount remained in the patient's body.No images were provided which could confirm this.Root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to off-axis or excessive forces applied during insertion or removal.Dhr review: the dhr was reviewed.There are no indications of manufacturing issues which would have contributed to this event and the device was likely conforming when it left highridge medical¿s control.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.

• Brand Name: CURVE SPACER 8MM 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: 21410313
• Report Number: 3012447612-2025-00053
• Device Sequence Number: 9455781
• Product Code: MAX
• UDI-Device Identifier: 00888480611493
• UDI-Public: (01)00888480611493(17)321216(10)096215
• 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
• 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,Followup
• Report Date (Section B): 07/20/2025

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: Health Professional
• Device Catalogue Number: 14-533128
• Device Lot Number: 096215
• Was Device Available for Evaluation?: Yes
• 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; Not provided
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 03/24/2025; 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2023
• 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: ZYSTON INSERTER, UNKNOWN TYPE
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 81 KG
• Patient Ethnicity: Non Hispanic