MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EIT PLIF, H 11MM, 12°, 22/9; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number PUI31102

Device Problems Entrapment of Device (1212); Device-Device Incompatibility (2919)

Patient Problems Foreign Body In Patient (2687); Insufficient Information (4580)

Event Date 01/29/2024

Event Type  Injury  

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: unknown event date.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h6: 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

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 on (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 one eit plif, h 11mm, 12°, 22/9 for (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: 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

Patient status and outcome resulted in the cage being removed the following day through an endoscopic anterior procedure.No issues were noted.

• Brand Name: EIT PLIF, H 11MM, 12°, 22/9
• Type of Device: 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): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 18679317
• MDR Text Key: 335073289
• Report Number: 1526439-2024-00871
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170503 AND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PUI31102
• Device Lot Number: 126944
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female