MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH T HANDLE INSERTER; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	PET30101T
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on unknown date, during an l2-5 posterior lumbar interbody fusion, surgeon inserted conduit cage item into the l2-3 disc space on the left hand side.He unthreaded the implant holder then decided that he wanted to pull the cage posterior 2mm so he attempted to reengage the implant holder onto the cage.He struggled to reengage the holder, and due to downward force he pushed the cage anterior and lateral to the disc space.He tried to retrieve the cage but was unsuccessful.After numerous attempts to get access to pull the cage back he decided to move forward with finishing the procedure and instead have a different specialty retrieve the cage at a later time through an anterior retroperitoneal approach.Surgeon then finished the procedure with no issues.The patient needs to return to the operating room to have the cage removed ((b)(6) 2024) there was a 60-90 minute surgical delay.General and vascular surgeons were called to understand the issue and create a plan for retrieving the cage at a later time.The general and vascular surgeons came to the operating room to see if the cage could be removed posteriorly.They decided it could not so the plan changed to them bringing the patient back to operating room at a later time to retrieve the cage from an anterior approach.The implant migrated anterior to the disc space which is not the intended location.Therefore, an additional surgery is needed to retrieve the implant.This report is for an unk insertion instrument: eit.This is report 2 of 2 for (b)(4).
Additional 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.B3: event occurred on an unknown date in 2024.D1, d2, d3, d4, g4 ¿ 510k: this report is for an unknown insertion instrument: eit/unknown lot.Part and lot numbers are unknown; udi number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: 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.
Event or Problem Description
Patient status and outcome resulted in the cage being removed the following day through an endoscopic anterior procedure.No issues were noted.
Additional 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: b3: event date -added.Bb: event description -updated.D4: catalog and lot numbers -added.D6a:implantation date- added.D6b: explanation date -added.G4.Pma/ 510(k)- added.Device was used for treatment, not diagnosis.

• Brand Name: T HANDLE INSERTER
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): EIT EMERGING IMPLANT TECHNOLOGIES GMBH; GM
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle, MA 02400 ; SZ 02400 ; 3035526892
• MDR Report Key: 18776499
• Report Number: 3013730328-2024-00032
• Device Sequence Number: 6188647
• Product Code: MAX
• UDI-Device Identifier: 10705034558097
• UDI-Public: 10705034558097
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K210728
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• 2 Devices were Involved in the Event: 1 2

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: PET30101T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2024
• Supplement Date Received by Manufacturer: 02/29/2024
• Initial Report FDA Received Date: 02/26/2024
• Supplement Report FDA Received Date: 03/13/2024
• 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
• Patient Age: 65 YR
• Patient Sex: Female