MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. CURVE SPACER 7MM X 27MM 6DEG PEEK LORDOTIC; ZYSTON ARC INTERBODY SPACER

Catalog Number	14-533127
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.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.
Event or Problem Description
It was reported that while the surgeon was lightly tamping on the implant holder, the cage broke.A piece of the implant remained on the holder and the other piece remained in the patient.An x-ray revealed the piece of the implant that remained in the patient was well located inside the disc space so the surgeon decided to leave it implanted.There were no reported patient impacts.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information and initially corrected information.Summary: the complaint is confirmed for one (1) of one (1) returned zyston curve cage (pn 14-533127) for the failure of fracture during insertion.This device is used for treatment.No medical records were provided with the complaint.Inspection: visual inspection confirms that the product is fractured into multiple pieces with parts of the item missing.Dhr review: the dhr could not be located and therefore could not be reviewed.Potential root cause: a definitive root cause cannot be determined with the information provided.A follow-up report will be submitted if new information is received that changes the information provided in this report.
Event or Problem Description
It was reported that while the surgeon was lightly tamping on the implant holder, the cage broke.A piece of the implant remained on the holder and the other piece remained in the patient.An x-ray revealed the piece of the implant that remained in the patient was well located inside the disc space so the surgeon decided to leave it implanted.There were no reported patient impacts.

• Brand Name: CURVE SPACER 7MM X 27MM 6DEG PEEK LORDOTIC
• Common Device Name: ZYSTON ARC INTERBODY SPACER
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 10681672
• Report Number: 3012447612-2020-00578
• Device Sequence Number: 571907
• Product Code: MAX
• UDI-Device Identifier: 00888480611486
• UDI-Public: (01)00888480611486(17)261213(10)068437
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K110650
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2021

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: 068437
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/17/2020
• Supplement Date Received by Manufacturer: 03/09/2021
• Initial Report FDA Received Date: 10/14/2020
• Supplement Report FDA Received Date: 03/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1