MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. SOLITAIRE-C SPACER 7HX16WX14D-L; SOLITAIRE-C CERVICAL SPACER SYSTEM

Catalog Number	14-520537
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2022
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 a solitaire-c spacer disassembled after insertion into the patient: after the cage was attached to the inserter and inserted into the body, the implant disassembled into its subcomponent pieces when the drill sleeve was being attached.Another cage was used to complete the surgery without reported patient impacts.
Additional Manufacturer Narrative
Device evaluation: visual inspection revealed that the device was returned disassembled.There was no damage to any of the sub-components and the device was able to be reassembled without issue.Root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to off-axis forces applied during use.Dhr review: per dhr review, the part was likely conforming when it left zimvie 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.
Event or Problem Description
It was reported that a solitaire-c spacer disassembled after insertion into the patient: after the cage was attached to the inserter and inserted into the body, the implant disassembled into its subcomponent pieces when the drill sleeve was being attached.Another cage was used to complete the surgery without reported patient impacts.

• Brand Name: SOLITAIRE-C SPACER 7HX16WX14D-L
• Common Device Name: SOLITAIRE-C CERVICAL SPACER SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer (Section G): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; na; westminster CO 80021
• Manufacturer Contact: kim martinez ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 16000196
• Report Number: 3012447612-2022-00291
• Device Sequence Number: 12204245
• Product Code: OVE
• UDI-Device Identifier: 00880304909007
• UDI-Public: (01)00880304909007(10)3046461
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K113796
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2023

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: 14-520537
• Device Lot Number: 3046461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2022
• Supplement Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 12/16/2022
• Supplement Report FDA Received Date: 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2019
• 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