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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH T-PAL ADVANCED APPLICATOR INNER SHAFT; INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR
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SYNTHES GMBH T-PAL ADVANCED APPLICATOR INNER SHAFT; INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR Back to Search Results
Catalog Number 03.812.521
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/21/2020
Event Type  malfunction  
Manufacturer Narrative
Reporter is (b)(6) representative.The device was received, the investigation is in progress, 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 Description
Device report from (b)(6) reports an event as follows: it was reported on (b)(6) 2020 that the patient underwent for a surgery.During the surgery, the proti cage was disengaged from the advanced applicator.A resistance was encountered when the 10mm proti cage was inserted.The disengaged implant was removed through another incision from anterior approach.Synfix evolution was used to fuse l5-s1.The surgery was completed successfully without delay reported.The patient outcome was unknown.Concomitant device reported: unk - impaction inst: hammer/mallet: (part# unknown; lot# unknown; quantity: unknown).This complaint involves four (4) devices.This report is for (1) t-pal advanced applicator inner shaft.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 visual and the functional investigation didn¿t detect any major issues with the returned items.There is normal wear and tear and the devices could be used as intended.According to the complaint description there was a ¿great resistance¿ when the cage was inserted and the surgeon ¿hammered hardly with mallet¿.Hammering might be needed to insert the implant but should only be ¿controlled and light¿ (see surgical technique, page 21).Hard hammering should not be required if the disc space is prepared sufficiently and a proper discectomy was done.Hence, hard hammering should not be done during the procedure.After the cage was released for pivoting hard hammering was applied again to turn the cage.An additional section can be found what to do if the implant does not pivot automatically.The need of hard hammering to insert and turn the cage is unusual and should be avoided.Hard hammering can potentially lead to a situation where the cage breaks through the anterior wall.As it can be seen in the x-rays, the implant was already over-pivoted.In this situation it can potentially happen that the cage disengages from the applicator as described in the complaint.Insufficiently removed disc material might be the cause of the described issues.The investigation did not discover any issues related to instruments or implant.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot part: 03.812.521, lot: 3l09323, manufacturing site: haegendorf, release to warehouse date: 13.Feb.2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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.
 
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: g1: physical manufacturer.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.H11: corrected data: h4.
 
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Brand Name
T-PAL ADVANCED APPLICATOR INNER SHAFT
Type of Device
INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key10861888
MDR Text Key245698307
Report Number8030965-2020-09024
Device Sequence Number1
Product Code MAX
UDI-Device Identifier07612334143785
UDI-Public(01)07612334143785
Combination Product (y/n)N
PMA/PMN Number
K181231
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 10/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number03.812.521
Device Lot Number3L09323
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/10/2020
Date Manufacturer Received01/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ADVANCED APPL OUTER SHAFT.; APPLICATOR KNOB.; UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: SPINE.
Patient Age60 YR
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