MAUDE Adverse Event Report: SYNTHES GMBH PSI SD800.439 PEEK IMPLANT; PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE

Catalog Number SD800.439

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 10/05/2022

Event Type  malfunction  

Event Description

Device report from synthes reports an event in northern ireland as follows: it was reported that on (b)(6) 2022, the patient underwent surgery with a patient specific plate.The patient specific plate was produced incorrectly and was not the correct plate for the patient.It was from the scans of another patient.The patient specific team have indicated via email that they mixed up patient scans in their planning stage and sent incorrect plans to the surgeon.The patient was on the operating table at the point of discovery that the plate was not appropriate, and the plate had to be cut and shaped in order to make it fit.The fit was deemed appropriate following this however not exact as per expectations of a pre-made psi.The surgery was completed successfully with significant adaptions to the psi plate made.There was a delay of 90 minutes to complete the procedure.There was no injury to the patient.No further information is available.This report involves one psi sd800.439 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.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.Product code: sd800.439, lot no: 861p18, manufacturing site: (b)(4), release to warehouse date: 02 jun 2022, a manufacturing record evaluation was performed for the not sterile finished lot number, and no non-conformances were identified.The product was not returned to depuy synthes for evaluation.The depuy synthes r&d team conducted a design review for this case.The design review found that the incorrect file was used to design the implant, psi 120*120*40 peek, product code sd800.439, for this case.The design was correct for the file used but the incorrect file was used, therefore the complaint is confirmed and the cause traced to the design of the implant.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 SD800.439 PEEK IMPLANT
• 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 6805 ; SZ 6805
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15924400
• MDR Text Key: 308073107
• Report Number: 8030965-2022-10704
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SD800.439
• Device Lot Number: 861P181
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female