MAUDE Adverse Event Report: SYNTHES GMBH T-PAL SPACER APPLICATOR INNER SHAFT; INTERVERTEBAL FUSION DEVICE W/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	04/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is expected to be returned for manufacturer review/ investigation but has yet to be received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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
Device report from synthes reports an event in (b)(6) as follows: it was reported on (b)(6) 2021, the patient underwent for a surgery.During the surgery, the advanced applicator outer shaft was stuck.The implant was removed easily but unable to unassembled the instrument.The surgery went well.The patient outcome was unknown.Concomitant device reported: unknown transforaminal posterior atraumatic lumbar (t-pal) implant (part# unknown, lot# unknown, quantity 1).This complaint involves three (3) devices.This report is for (1) t-pal spacer applicator inner shaft.This report is 2 of 3 (b)(4).

• Brand Name: T-PAL SPACER APPLICATOR INNER SHAFT
• Common Device Name: INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11866977
• Report Number: 8030965-2021-04152
• Device Sequence Number: 19764249
• Product Code: MAX
• UDI-Device Identifier: 07611819414600
• UDI-Public: 07611819414600
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/26/2021

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 05/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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: ADVANCED APPL OUTER SHAFT; APPLICATOR KNOB; UNK - CAGE/SPACERS: T-PAL