MAUDE Adverse Event Report: EIT EMERGING IMPLANT TECHNOLOGIES GMBH IMPLANT INSERTER; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	LET30100
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, during a procedure the instrument became blocked and could not be used to insert the instrument.There was no surgical delay.Another system was used to complete the procedure.There was no consequence to the patient.This report involves one (1) implant inserter.This is report 1 of 1 for pc-(b)(4).
Additional Manufacturer Narrative
Only event year is known.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is (b)(6).Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: IMPLANT INSERTER
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): EIT EMERGING IMPLANT TECHNOLOGIES GMBH; eisenbahnstrasse 84; wurmlingen D-785 73; DE D-78573
• Manufacturer (Section G): EIT EMERGING IMPLANT TECHNOLOGIES GMBH; GM
• Manufacturer Contact: daniel seng ; eisenbahnstrasse 84; wurmlingen D-785-73 ; GM D-78573 ; 6103142063
• MDR Report Key: 12861030
• Report Number: 3013730328-2021-00057
• Device Sequence Number: 14526280
• Product Code: MAX
• UDI-Device Identifier: 04260557837733
• UDI-Public: (01)04260557837733
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K181644
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/25/2021

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 Model Number: LET30100
• Device Catalogue Number: LET30100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN CAGE/SPACER
• Patient Sex: Unknown