MAUDE Adverse Event Report: SYNTHES GMBH PSI SD800.427 PEEK IMPLANT; PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE

Catalog Number SD800.427

Device Problem Defective Device (2588)

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

Event Date 01/01/2022

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.Complainant part is not expected to be returned for manufacturer review/investigation.Therapy date: (b)(6) 2022.Without a lot number the device history records review could not be completed.Product was not returned.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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that during a procedure on (b)(6) 2022, the patient specific implant was not fitting perfectly.In order to match the implant with patient's anatomy/defect surgeon had to apply other techniques (milling) to fit the implant.At the end it worked and the implant could be placed.It was also reported that the cutting guide allowed for more than 1 matching position and this should normally not be the case.Both the cutting guide and the implant were not perfectly matching with the defect.The physician had to add more time to adjust the implant to the patients anatomy.This caused a slight delay.The overall procedure went well and patient outcome is reported as doing well.This report is for one (1) psi 100*80*40 peek 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.A1: patient id: (b)(6).D4, h3, h4, h6: part sd800.427, lot 748p865: manufacturing site: mezzovico.Release to warehouse date: march 25, 2022.A manufacturing record evaluation was performed for the not sterile finished lot number, and no non-conformances were identified.H3, h6: a research and development (r&d) investigation was completed: the product was not returned to depuy synthes.The r&d team conducted an investigation of the device from the case records and complaint documentation.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 and the received details on the case.No images intra or post operatively were available for review.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.Based on the information and documents available, this design investigation is closed as not valid regarding a design related root cause.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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: PSI SD800.427 PEEK IMPLANT
• 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 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14597020
• MDR Text Key: 301559361
• Report Number: 8030965-2022-03674
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 07611819341302
• UDI-Public: (01)07611819341302
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K053199
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SD800.427
• Device Lot Number: 748P865
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: PATIENT SPECIFIC GUIDE CRANIUM, FOREHEAD; PATIENT SPECIFIC GUIDE CRANIUM, FOREHEAD; UNK - CUTTING INSTRUMENTS: CMF
• Patient Age: 19 YR
• Patient Sex: Male