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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH T-PAL SPACER APPLICATOR KNOB; INTERVERTEBRAL FUSION DEVICE W/BONE GRAFT, LUMBAR
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OBERDORF SYNTHES PRODUKTIONS GMBH T-PAL SPACER APPLICATOR KNOB; INTERVERTEBRAL FUSION DEVICE W/BONE GRAFT, LUMBAR Back to Search Results
Catalog Number 03.812.004
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Injury (2348)
Event Date 10/07/2020
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 a l5-s1 tlif procedure was scheduled for (b)(6) 2020.Sets were delivered late after booking was made the previous day.The patient was moved to a later surgery slot.After patient was put under anesthesia, it was discovered that the stock of the vcffs screws was delivered incomplete after arrangement had been made to transfer stock from another set.There were not enough 6 x 45mm screws, and surgeon had to compromise by using a size that was available.During this time, it was also discovered that the tpal set was packed with the wrong inner tray and that all the instruments to be used to insert the cage were missing.This led to longer surgical time while the surgeon had to wait for instruments to be shipped to the hospital.Upon arrival, only the old inserter shaft, which was bulky, was delivered, which abetted in the surgeon damaging the dura of the spinal cord upon insertion of the cage.Procedure was completed successfully with a delay of fifteen to twenty (15-20) minutes.This report is for a t-pal spacer applicator knob.This is report 3 of 10 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.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
This is report 3 of 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.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
Updated event description: concomitant device reported: unknown cage (part # unknown, lot # unknown, quantity unknown).
 
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Brand Name
T-PAL SPACER APPLICATOR KNOB
Type of Device
INTERVERTEBRAL FUSION DEVICE W/BONE GRAFT, LUMBAR
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key10792109
MDR Text Key217316769
Report Number8030965-2020-08610
Device Sequence Number1
Product Code MAX
UDI-Device Identifier07611819414624
UDI-Public(01)07611819414624
Combination Product (y/n)N
PMA/PMN Number
K151276
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 10/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number03.812.004
Was Device Available for Evaluation? No
Date Manufacturer Received11/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
APPLICAT OUT SHAFT; APPLICAT OUT SHAFT; APPLICATOR INNER SHAFT; APPLICATOR INNER SHAFT; UNK - CAGE/SPACERS: T-PLIF; UNK - CAGE/SPACERS: T-PLIF; UNK - HANDLES; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX
Patient Outcome(s) Required Intervention;
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