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

Model Number LET30100

Device Problems Break (1069); Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/28/2022

Event Type  malfunction  

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.

Event Description

Device report from synthes reports an event in united kingdom as follows: it was reported on (b)(6) 2022 that the conduit llif inserter broke and wouldn¿t release the implant.The implant had to be removed and another one opened as it couldn¿t be taken off the inserter.There was minimal delay and the case went well in the end with the patient doing well now.This report is for one (1) implant inserter this is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: h3, h4, h6 investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and 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 history: part/lot combination is not valid, and device is not being returned, therefore, dhr could not be completed.If the device is returned or lot number can be confirmed, the dhr will be revisited.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
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): EIT EMERGING IMPLANT TECHNOLOGIES GMBH; eisenbahnstrasse 84; wurmlingen D-785 73
• Manufacturer (Section G): EIT EMERGING IMPLANT TECHNOLOGIES GMBH; eisenbahnstrasse 84; wurmlingen D-785 73
• Manufacturer Contact: daniel seng ; eisenbahnstrasse 84; wurmlingen D-785-73 ; 6103142063
• MDR Report Key: 16042132
• MDR Text Key: 308364652
• Report Number: 3013730328-2022-00101
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K181644
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LET30100
• Device Catalogue Number: LET30100
• Device Lot Number: E19DI1313
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1