MAUDE Adverse Event Report: SYNTHES GMBH PSI 140*100*40 PEEK; PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE

Catalog Number SD800.435

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 02/15/2023

Event Type  Injury  

Event Description

Device report from synthese reports an event in south korea as follows: they removed psi due to an infection in the patient's operated area.(this patient had a previous history of infection.) did the patient experience an adverse event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing? yes.Did the patient require revision surgery or hardware removal? yes.Was device explanted? yes did patient require revision surgery? yes patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)? infection this report is for one (1)psi 140*100*40 peek this is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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.Reporter is a j&j sales representative.Postal code 6805 product code: sd800.435 lot no: 1697p55 manufacturing site: mezzovico release to warehouse date: (b)(6) 2022 a manufacturing record evaluation was performed for the not sterile finished lot number, and no non-conformance's were identified.Product was not returned.Based on the information available, it has been determined that no corrective and 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.

• Type of Device: PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico
• Manufacturer Contact: kate karberg ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 3035526892
• MDR Report Key: 16528710
• MDR Text Key: 311131956
• Report Number: 8030965-2023-03016
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 07611819341357
• UDI-Public: (01)07611819341357
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SD800.435
• Device Lot Number: 1697P55
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention