MAUDE Adverse Event Report: SYNTHES GMBH CUSTOM-MADE DEVICE TRUMATCH CMF PEEK MIL; PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE

Catalog Number SD802.841

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/29/2022

Event Type  malfunction  

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.Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.Device is not distributed in the united states, but is similar to device marketed in the usa.Reporter is a j&j sales representative.Without a lot number the device history records review could not be completed.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 depuy synthes reports an event in spain as follows: it was reported that the patient's specified implant arrived to the hospital with visible damage and as a result the psi implanted in the patient's cranio wasn't good.The cranio and the psi wasn't fixed well and there is an obvious relief in the face with possibility to do a revision surgery.No further information provided.This report is for one (1) custom-made device trumatch cmf peek mil this is report 1 of 1 for complaint (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.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

There was no surgical delay.The surgery was successfully completed.

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.Additional narrative: h3, h4, h6: product code: sd802.841.Product name: custom-made device trumatch cmf peek mil lot: 1064p44.Manufacturer: monument.Manufacturing date: july 18, 2022.The product was returned to depuy synthes and sent to manufacturing site: monument for evaluation.The monument team conducted a visual inspection of the returned device.Per the complaint description, the psi case files, and communication were reviewed.The investigation included an end-to-end process review of the documentation and forms along with the surgeon complaint report including the provided post operative images and the returned device.The implant design was completed and verified as per the depuy synthes design instructions and roles.After the surgeon reviewed the design and approved it (with his signature), the device was produced and inspected according to process and released upon acceptable quality inspection.At present, the returned device was produced correctly and there is no sign of ¿visible damage¿ aside from the burred section.Several potential factors which may have contributed to the complaint description may be as a result of malpositioning, possibly as a result of non-uniform defect/residual bone (e.G.From the removal of the native flap), or possibly due to the temporalis muscle sharing the inferior defect margin.Although these two potential factors are not definitive root causes, nor do they effect the design or production of the device, the post-operative scan that was shown in the complaint images may be used to further determine root cause relative to the complaint description.This post-operative scan would be needed to draw a more conclusive root cause determination.The investigation found that the returned device was designed and produced correctly.There is not enough data to determine the root cause of the issue as described in the complaint.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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: CUSTOM-MADE DEVICE TRUMATCH CMF PEEK MIL
• Type of Device: PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 15490340
• MDR Text Key: 303046316
• Report Number: 8030965-2022-07376
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 07612334121585
• UDI-Public: (01)07612334121585
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SD802.841
• Device Lot Number: 1064P44
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/17/2022
• Initial Date FDA Received: 09/27/2022
• Supplement Dates Manufacturer Received: 09/28/2022; 07/18/2023
• Supplement Dates FDA Received: 10/18/2022; 07/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Sex: Male
• Patient Weight: 70 KG