MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PSI SD800.434 PEEK IMPLANT; PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE

Catalog Number SD800.434

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Code Available (3191)

Event Date 05/29/2018

Event Type  Injury  

Manufacturer Narrative

Patient date of birth/age and weight were not provided for reporting.Device malfunctioned intraoperative.Device was not implanted/explanted.Device is expected to be returned for manufacturer review/investigation, but has not been received yet.Reporter contact number was not provided.(b)(4).The investigation could not be completed; no conclusion could be drawn, as no product was received.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 procedure on (b)(6) 2018, wrong size of the prosthesis was made.It was too big in comparison with the cranial defect.The intervention was concluded using another material.There was no patient harm.Surgery was completed successfully without delay.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.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.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.A device history record review 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.Part: sd800.434.Lot: l787384.Manufacturing site: mezzovico release to warehouse date: 16.Feb.2018.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 and visual criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.Visual inspection: the received device is in a good condition and does not show any damages.Functional test: we have forwarded the complaint to the responsible product manager with the following results: based on the provided screen shot from the hospital imagine system it looks like the surgeon only wanted to close to lower gap indicated in black in these pictures.The standard design guide for peek psi recommends to remove remaining old implants and / or remaining but resorbing bone elements.Based on this standard the peek psi was designed for the complete defect present, without taking the reconstruction or bone flap in consideration, that was already present in the relative ct data-set.This was also reflected accordingly in the images for approval, that where released by the surgeon on the 9th of february 2018.Normally a required design change of the provided peek psi design is requested at this stage.As the surgeon did sign the images for approval, the peek psi was designed and delivered accordingly.Our investigation has shown that the complaint condition is rated as confirmed due to the investigation outcome from the product manager.Based on the above discussed situation (functional test) the root cause has been identified.The related findings should be shared with the reporting sales organization as well as with the reporting surgeon.Based on the above evaluation, 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 as no product related issue could be detected.Finally, we conclude that the cause of failure is not due to any manufacturing non-conformance's.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.

• Brand Name: PSI SD800.434 PEEK IMPLANT
• Type of Device: PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7619755
• MDR Text Key: 111702979
• Report Number: 8030965-2018-54436
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 07611819341340
• UDI-Public: (01)07611819341340
• Combination Product (y/n): N
• PMA/PMN Number: K053199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SD800.434
• Device Lot Number: L787384
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2018
• Date Manufacturer Received: 12/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR