MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. PLUG; EBI 5.5 HELICAL FLANGE SPINAL SYSTEM

Catalog Number	2000-1005
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2021
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.Reference reports 3012447612-2021-00463 through 3012447612-2021-00467.
Event or Problem Description
It was reported five polaris plugs stripped intraoperatively.They were removed and replaced without patient impacts.This is report four of five for this event.
Additional Manufacturer Narrative
Corrections in d4: lot number and udi number, d9, h3, and h4.Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation the returned devices match the information in the complaint file and were examined.There were five returned closure tops, however one was lost in the wash process (lot j6427145) and is unable to be inspected.The four that were able to be inspected revealed stripped hex on three (lot numbers j6364237, j6392969 and j6435242) and one with damaged threads (lot j6364237).Potential cause: root cause was unable to be determined.This event could possibly be attributed to applying off-axis forces during insertion.Dhr review: per dhr review, the parts were likely conforming when they left zimmer biomet control.Device use: this device is used for treatment.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 five polaris plugs stripped intraoperatively.They were removed and replaced without patient impacts.This is report four of five for this event.

• Brand Name: PLUG
• Common Device Name: EBI 5.5 HELICAL FLANGE SPINAL 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: 13046037
• Report Number: 3012447612-2021-00466
• Device Sequence Number: 1728253
• Product Code: MNH
• UDI-Device Identifier: 00888480207115
• UDI-Public: (01)00888480207115(11)181127(10)J6427145
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K061441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 02/22/2022

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: 2000-1005
• Device Lot Number: J6435242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2022
• 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: 11/25/2021
• Supplement Date Received by Manufacturer: 01/28/2022
• Initial Report FDA Received Date: 12/20/2021
• Supplement Report FDA Received Date: 02/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2018
• 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 Age: 59 YR
• Patient Sex: Male
• Patient Weight: 80 KG