MAUDE Adverse Event Report: SYNTHES GMBH T-PAL TI SPACER 12MM X 32MM 11MM HEIGHT - STERILE; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number 04.812.211S

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 06/07/2021

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.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 Description

Device report from (b)(6) reports an event as follows: it was reported that following implantation on (b)(6) 2021, a t-pal tan 11mm was observed on x-ray control to not be deep enough into the intervertebral space.The surgeon used the dedicated t-pal impactor, curved to push the cage forward.There was initial resistance then, suddenly, the t-pal impactor plunged down.The surgeon immediately asked for a control x-ray which showed the t-pal cage had turned 180°, with blunt nose toward the medulla canal.The surgeon opted to remove it immediately and tried at first by a counter minimal incision.Then, having not enough space to place the t-pal removal instrument, the surgeon moved back to the first side percutaneous incision and took a big kocher forceps to successfully remove the t-pal cage.No obvious co-lateral damage was observed on the patient.The surgeon made the decision to move away from any implant at this time, to close the wound of the patient, and to place them under strict post-op monitoring control; if there were no drawback, to reoperate later.There was a surgical delay of fifty-five (55) minutes.This report is for a t-pal titanium (ti) spacer.This is report 1 of 1 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.H3, h4, h6- the device was not returned.A photo-investigation was performed upon inspecting the image provided, the t-pal cage was observed to have rotated off axis and misplaced in the patient's spinal canal.It was reported that the surgeon used incorrect instrument handling (sudden overpressure on the cage) while pushing the cage forward into the intervertebral space using the t-pal impactor, hence causing the incident.The root cause for the reported event is attributed to user error.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.Conclusion: the complaint condition can be confirmed during photo investigation.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.A dhr review could not be performed as the device lot number is unknown.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: T-PAL TI SPACER 12MM X 32MM 11MM HEIGHT - STERILE
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12014061
• MDR Text Key: 256752458
• Report Number: 8030965-2021-05013
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 07611819459311
• UDI-Public: (01)07611819459311
• Combination Product (y/n): N
• PMA/PMN Number: K151276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.812.211S
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/07/2021
• Initial Date FDA Received: 06/16/2021
• Supplement Dates Manufacturer Received: 06/30/2021
• Supplement Dates FDA Received: 07/16/2021
• Patient Sequence Number: 1
• Treatment: IMPACT CURV STD; IMPACT CURV STD
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Weight: 105