MAUDE Adverse Event Report: SYNTHES GMBH T-PAL SPACER APPLICATOR INNER SHAFT; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	03.812.003
Medical Device Problem Code	Compatibility Problem (2960)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from (b)(6) reports an event as follows: it was reported that patient underwent a spinal fusion (l4/5) for treating vertebral canal stenosis on (b)(6) 2022.The surgeon deployed the implant with the help of a hammer.Next, the surgeon tried to detach the applicator inner shaft, however, both tightly stuck together and were not able to be separated.The surgeon prepared a replacement applicator inner shaft and an implant and completed the rest of the procedure without surgical delay.The surgeon later confirmed that he did not appropriately connect the applicator inner shaft in question and the implant.Patient was stable.This report is for a t-pal spacer applicator inner shaft.This is report 1 of 1 for (b)(4).Additional reports are captured under (b)(4).
Additional Manufacturer Narrative
Additional 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.

• Brand Name: T-PAL SPACER APPLICATOR INNER SHAFT
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13587870
• Report Number: 8030965-2022-01093
• Device Sequence Number: 11727503
• Product Code: MAX
• UDI-Device Identifier: 07611819414600
• UDI-Public: (01)07611819414600
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151276
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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 Catalogue Number: 03.812.003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 02/23/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: T-PAL PROTI, 10X9X28 MM.
• Patient Sex: Unknown