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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PSI SD800.440 PEEK IMPLANT; PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE
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OBERDORF SYNTHES PRODUKTIONS GMBH PSI SD800.440 PEEK IMPLANT; PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE Back to Search Results
Catalog Number SD800.440
Device Problem Fitting Problem (2183)
Patient Problem No Code Available (3191)
Event Date 03/27/2018
Event Type  Injury  
Manufacturer Narrative
Patient weight was not provided for reporting.Device malfunctioned intraoperative.Device was not implanted/explanted.(b)(4).The device was received and the product evaluation is in progress.No conclusion can be drawn.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 synthes europe reports an event in (b)(6) as follows: it was reported that during the surgery on (b)(6) 2018, the patient specific peek implant did not fit.Reportedly, the implant was replaced with the non-synthes device (palacos).Patient consequences were not reported.This report is for one (1) (b)(4) peek implant.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.Additional narrative: dhr review was completed.Part no.: sd800.440, lot no.: l817118, and manufacturing location: (b)(4).Release to warehouse date: 07.Mar.2018.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Customer quality conducted an investigation of the returned device.The complained patient specific implant (psi) was forwarded to the responsible product development center and was checked for conformance to the specifications.The review of the device history record revealed that this implant was manufactured in march 2018 according to the specifications.Abstract from pd report: it was reported that the peek psi did not fit in the patients defect at all.The peek psi had some gaps with at least 20mm distance to the patient¿s remaining bone.We did analysis the ct scan dataset and saw, that the ct scan was provided with an 8-degree gantry tilt.The gantry tilt situation was highlighted from materialise, that did segment the ct data for this case, via the sales representative to the radiologist department of the kantonsspital aarau.Two options where presented with a positive gantry tilt correction (direction a) and a negative gantry tilt correction (direction b).Based on a telephone confirmation from the radiology department, the sales representative did confirm the use of direction b (feet up) to materialise.This negative gantry tilt correction, was then used for the design of the implant and was also represented in the approval documentation, that was signed by the surgeon.During this complaint evaluation we did then also segment the ct dataset with the positive gantry tilt correction and did digitally try to align the peek psi into it.These pictures look similar to the above complaint description.In addition the same set up could be reproduced with the returned peek psi.Based on the discussion with the sales representative, it was confirmed, that the chief surgeon from the kantonsspital aarau, did request the sales representative to no longer contact his assistant doctors to clarify the gantry tilt correction and to clarify this topic directly with the radiology department of the hospital.Generally, we are requesting ct datasets with no gantry tilt.If there is a gantry tilt, we can continue with the case, once we have the related surgeon¿s approval to use the corrected data according the communication shown above.If the surgeon or the surgeon¿s manager is outsourcing the responsibility of this decision, he does this in his responsibility.In addition, the surgeon has also to sign the final images before the peek psi will be produced.This document is defining the design and the specification of the patient specific implant.In this case, a relative product, based on a wrong dataset was approved twice within the hospital organization and the peek psi was produced accordingly.The complaint will be closed as not valid, as there was no process- or product failure detected for the product design and production phase.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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.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 synthes europe reports an event in switzerland as follows: it was reported that during the surgery on (b)(6) 2018 , the patient specific polyether ether ketone (peek) implant did not fit.Reportedly, the implant was replaced with the non-synthes device (palacos).Surgery was completed successfully with a delay of approximately 1 hour.Patient consequences were not reported.This report is for one (1) psi sd800.440 peek implant.This is report 1 of 1 for (b)(4).
 
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Brand Name
PSI SD800.440 PEEK IMPLANT
Type of Device
PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key7413299
MDR Text Key105150331
Report Number8030965-2018-52949
Device Sequence Number1
Product Code GXN
UDI-Device Identifier07611819341388
UDI-Public(01)07611819341388(10)L817118
Combination Product (y/n)N
PMA/PMN Number
K053199
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 03/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberSD800.440
Device Lot NumberL817118
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/09/2018
Date Manufacturer Received05/17/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age23 YR
Patient Weight57
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