MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PSI 140*120*40 PEEK; PLATE, CRANIOPLASTY, PREFORMED NONALTERABLE

Catalog Number SD800.440

Device Problem Defective Device (2588)

Patient Problems Injury (2348); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.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 during a cranioplasty on an (b)(6) 2020, it was noted that the implant's radian was not enough, it was too even/flat; when inserting the implant, it was noted the implant fit the defect cranial flap closely, not any gaps.On an unknown postoperative date, the patient was returned to the hospital due to severe asymmetry of the skull on both sides.Ct showed that the skull on both sides was indeed asymmetric and the repaired side was too flat.The patient is stable now and the therapeutic schedule hasn't been determined.This report is for a psi 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: b5; d4.H6: per the investigation description the psi case file was reviewed.The investigation included a review of the documentation and forms along with the surgeon report.The design was completed and verified as per the depuy synthes design instructions.The surgeon approved with his signature on the approval letter the design of the device.This complaint investigation did not identify a design defect or deficiency which potentially contributed to the reported complaint conditions.Therefore, this non-manufacturing investigation is closed by product development as undetermined regarding a design related root cause.The device was not received.A product development investigation was conducted based on the available product and patient information.Design review: an investigation was conducted into the device design to determine if the design contributed or caused the event of the described severe asymmetrical skull.With the device complaint we did not received any images or scans regarding the patient situation, 4 months post-op to assist in our device investigation and understanding on the descript asymmetry.The ct scan information for this case was shared with r&d on 16.04.2020 (reference item 4.9 ¿case timeline¿ in the pi attachment).Based on depuy synthes case records we received three (3) scans with this case request (two abdominal scans and one skull scan) related to a male patient of 28 years.The design review performed by product development of the uploaded scan data and that of the psi device concluded that the psi device fit and matched the patient scan data; no asymmetrical mismatch was seen.(reference pi attachment images 1 and 2, originating from the case approval letter document).The design for the implant was created according to the relevant work instruction for psi design (w-c-s030).The implant was designed with a standard thickness of 3 mm.The review of the case file ¿patient specific implant design review checklist¿ for this implant showed that the implant was reviewed and approved by an independent reviewer according to the relevant work instruction for psi design (se_039100_aa).Case timeline: (b)(6) 2020: the case data was received by depuy synthes r&d.(case id (b)(4)) (b)(6) 2020: the case has been created in the trumatch cmf internal case management system.(b)(6) 2020: the design has been completed and the approval letter was sent to the sales rep.(b)(6) 2020: surgeon approval was signed and received.(b)(6) 2020: the manufacturing files were checked and released for production.(b)(6) 2020: the device was produced.(b)(6) 2020: the device was shipped.(b)(6) 2020: planed surgery date.(b)(6) 2020: surgery was conducted.(b)(6) 2020: the complaint (b)(4) was received.Conclusion: the complaint was not confirmed during investigation.There were no issues during the manufacture of the device that would contribute to the complaint condition.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.H6: a device history record (dhr) review was conducted: part number: : sd800.440.Lot number: 55p1436.Manufacturing site: mezzovico.Release to warehouse date: 11 may 2020.A manufacturing record evaluation was performed for the not sterile 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.

Event Description

Concomitant device reported: unknown screws (part#: unknown, lot#: unknown, quantity: unknown ); unknown plate: (part#: unknown, lot#: unknown, quantity: 1).

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.H6: health effect clinician code 2402 used to capture procedural complications.H3, h6: part number: : sd800.440, lot number: 55p1436, manufacturing site: mezzovico, release to warehouse date: 11 may 2020.A manufacturing record evaluation was performed for the not sterile device lot number, and no non-conformances were identified.Per the investigation description above the psi case file was reviewed.The investigation included a review of the documentation and forms along with the surgeon report.The design was completed and verified as per the depuy synthes design instructions.The surgeon approved with his signature on the approval letter the design of the device.This complaint investigation did not identify a design defect or deficiency which potentially contributed to the reported complaint conditions.Therefore, this non-manufacturing investigation is closed by product development as undetermined regarding a design related root cause.Product was not returned therefore no further investigation possible.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 (information or/and material), 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.

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.H10 additional narrative: h3, h6: investigation summary: per the investigation description above the psi case file was reviewed.The investigation included a review of the documentation and forms along with the surgeon report.The design was completed and verified as per the depuy synthes design instructions.The surgeon approved with his signature on the approval letter the design of the device.This complaint investigation did not identify a design defect or deficiency which potentially contributed to the reported complaint conditions.Therefore, this non-manufacturing investigation is closed by product development as undetermined regarding a design related root cause.For further information see attached document "(b)(4)- complaint investigation_signed".Product was not returned therefore no further investigation possible.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 (information or/and material), the investigation will be updated as applicable.,complaint description radian issue.It was reported that during the surgery of cranioplasty,noted the implant's radian was not enough, it was too even/flat, when insert the implant, noted the implant was fit the defect cranial flap closely, no any gaps.After the operation, the patient was returned to the hospital due to severe asymmetry of the skull on both sides.Ct showed that the skull on both sides was indeed asymmetric and the repaired side was too flat.The patient is stable now and the therapeutic schedule hasn't been determined.The device was not received.A product development investigation was conducted based on the available product and patient information.Reference pi attachment "(b)(4)- complaint investigation_signed" (pi attachment) for complete investigation, which is summarized below.Design review: an investigation was conducted into the device design to determine if the design contributed or caused the event of the described severe asymmetrical skull.With the device complaint we did not received any images or scans regarding the patient situation, 4 months post-op to assist in our device investigation and understanding on the descript asymmetry.The ct scan information for this case was shared with r&d on (b)(6) 2020 (reference item 4.9 ¿case timeline¿ in the pi attachment).Based on depuy synthes case records we received three (3) scans with this case request (two abdominal scans and one skull scan) related to a male patient of 28 years.The design review performed by product development of the uploaded scan data and that of the psi device concluded that the psi device fit and matched the patient scan data; no asymmetrical mismatch was seen.(reference pi attachment images 1 and 2, originating from the case approval letter document).The design for the implant was created according to the relevant work instruction for psi design (w-c-s030).The implant was designed with a standard thickness of 3 mm.The review of the case file ¿patient specific implant design review checklist¿ for this implant showed that the implant was reviewed and approved by an independent reviewer according to the relevant work instruction for psi design.Conclusion: the complaint was not confirmed during investigation.There were no issues during the manufacture of the device that would contribute to the complaint condition.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.,we have forwarded the new received information to the sustaining engineering for re-evaluation, find the statement below: (b)(4)- complaint investigation_signed" our report to the case based on the information we had back in oct.2020.(see also (b)(4) or below) as i recall the surgeon was not happy with the feedback we gave him to the case.So he asked for an additional response/feedback.However, since we did not get the post-operative ct scan to investigate the plan vs.Outcome we cannot future comment here.Information from (b)(4): per the investigation description above the psi case file was reviewed.The investigation included a review of the documentation and forms along with the surgeon report.The design was completed and verified as per the depuy synthes design instructions.The surgeon approved with his signature on the approval letter the design of the device.This complaint investigation did not identify a design defect or deficiency which potentially contributed to the reported complaint conditions.Therefore, this non-manufacturing investigation is closed by product development as undetermined regarding a design related root cause.Product was not returned therefore no further investigation possible.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 (information or/and material), the investigation will be updated as applicable.Device history lot: part number: : sd800.440.Lot number: 55p1436.Manufacturing site: mezzovico.Release to warehouse date: may 11, 2020.A manufacturing record evaluation was performed for the not sterile device lot number, and no non-conformances were identified.,part number: : sd800.440.Lot number: 55p1436.Manufacturing site: mezzovico.Release to warehouse date: may 11, 2020.A manufacturing record evaluation was performed for the not sterile device lot number, and no non-conformances were identified.,part number: : sd800.440.Lot number: 55p1436.Manufacturing site: mezzovico.Release to warehouse date: may 11, 2020.A manufacturing record evaluation was performed for the not sterile device lot number, and no non-conformances were identified.Device history review: null,a manufacturing record evaluation was performed for the device lot number, and no non-conformances were identified.,null.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.

• Type of Device: PLATE, CRANIOPLASTY, PREFORMED NONALTERABLE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10686351
• MDR Text Key: 211640460
• Report Number: 8030965-2020-07964
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 07611819341388
• UDI-Public: (01)07611819341388
• 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: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SD800.440
• Device Lot Number: 55P1436
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/22/2020
• Initial Date FDA Received: 10/15/2020
• Supplement Dates Manufacturer Received: 10/20/2020; 02/02/2021; 02/02/2021
• Supplement Dates FDA Received: 11/04/2020; 02/03/2021; 03/01/2021
• Patient Sequence Number: 1
• Treatment: UNK - PLATES; UNK - SCREWS: TRAUMA
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR