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

Catalog Number	2000-1005
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Inspection: visual inspection of the plugs reveals that all of them have stripped threads.Dhr review: the dhrs were reviewed.There are no indications of manufacturing issues which would have contributed to this event and the devices were likely conforming when they left zimmer biomets control.Device usage: this device is used for treatment.Potential root cause: a definitive root cause cannot be determined with the information provided.Inserting the plugs in an off-axis manor may have contributed to this issue.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 3012447612-2021-00228.
Event or Problem Description
It was reported that five closure tops would not mate with their mating screw intra-operatively.They were removed and replaced with other closure tops without patient impacts.However, device evaluation by the manufacturer found the closure top threads were stripped.This is report five 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
• MDR Report Key: 12139181
• Report Number: 3012447612-2021-00232
• Device Sequence Number: 17137781
• Product Code: MNH
• UDI-Device Identifier: 00880304942721
• UDI-Public: (01)00880304942721(10)2677061
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/08/2021

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: 2000-1005
• Device Lot Number: J6810522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2021
• Initial Report FDA Received Date: 07/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1