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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH T-PAL SPACER APPLICATOR HANDLE; INTERVERTEBRAL FUSION DEVICE W/BONE GRAFT, LUMBAR
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OBERDORF SYNTHES PRODUKTIONS GMBH T-PAL SPACER APPLICATOR HANDLE; INTERVERTEBRAL FUSION DEVICE W/BONE GRAFT, LUMBAR Back to Search Results
Catalog Number 03.812.001
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/08/2018
Event Type  malfunction  
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a synthes employee.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 patient underwent an unknown surgery on (b)(6) 2018.During the procedure, while inserting the transforaminal posterior atraumatic lumbar (t-pal) small cage, the surgeon noted that the cage was a bit loose and further tightened the knob.The surgeon had impacted the applicator to insert the cage and upon trying to release the cage, the surgeon could press the ring down but could not open the knob.The cage could not be detached.Another applicator and cage were used to complete the surgery.It was unknown if there was a surgical delay.Patient outcome is unknown.Concomitant devices: t-pal spacer/cage (part: unknown, lot: unknown, quantity: 1).This report is for a t-pal spacer applicator handle.This is report 2 of 3 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.A review of the device history records has been requested.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.Device history records review was completed for part: 03.812.001, lot: l475758.Manufacturing location: hägendorf, release to warehouse date dec 22, 2017.The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and functional criteria at the time of release with no issues documented during the manufacturing process.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Product investigation was completed.The applicator inner shaft as well as the applicator outer shaft present surface wear consistent with use, this wear would not affect performance of the devices.The applicator knob is in good condition.A functional test to replicate the reported complaint condition of not releasing the implant was not able to be performed because the t-pal spacer implant involved was not returned.However, dimensional inspection and functional test were performed per 100% at the time of manufacturing with no non-conformities documented.The returned instruments could be assembled without any anomalies.The returned t-pal instruments were examined, and the complaint condition was not able to be confirmed.The review of the production history revealed that the instruments were manufactured according to the specifications (03.812.003 in february 2018, 03.812.001 in dec 2017, 03.812.004 in february 2018).The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements.Furthermore, these instruments are function checked per 100% before they leave the manufacturing site.No manufacturing related issues that would have contributed to this complaint were found; the damage occurred is determined to be post production/acceptance criteria.The t-pal spacer implant was not returned therefore no conclusive statement regarding the mentioned 'inability to release' can be given.However, the complained malfunction is most likely due to an inappropriate handling.Please note, the t-pal instrumentation and implants are designed to be inserted at an angle of 10°-15° to the sagittal plane.If this orientation is not maintained (<10°) or the implant is over rotated (>90° to the sagittal plane), it may result in jamming of the implant to the inner shaft as mentioned in the complaint description.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Lot number 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.
 
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Brand Name
T-PAL SPACER APPLICATOR HANDLE
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 Key8112110
MDR Text Key128738898
Report Number8030965-2018-58548
Device Sequence Number1
Product Code MAX
UDI-Device Identifier07611819405813
UDI-Public(01)07611819405813
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 11/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number03.812.001
Device Lot NumberL475758
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/15/2019
Date Manufacturer Received01/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age55 YR
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