MAUDE Adverse Event Report: SYNTHES GMBH UNK - PSI IMPLANTS; PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE

Catalog Number UNK - PSI IMPLANTS: TRAUMA

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

Patient Problem Cognitive Changes (2551)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown psi implant/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This report is being filed after the review of the following journal article: bianchi f., et al (2019) one-stage frame-guided resection and reconstruction with peek custom-made prostheses for predominantly intraosseous meningiomas: technical notes and a case series, neurosurgical review volume 42,pages 769¿775(italy).This retrospective study aims to report surgical series consisting of six consecutive patients harboring an intraosseous meningioma operated on between september 2014 and june 2018.Between september 2014 and june 2018, six patients (5 female and 1 male) with mean age at presentation 54 ± 10.83 years harboring predominantly intraosseous meningioma and who underwent surgery were retrospectively reviewed.In all cases, the custom-made prostheses made of peek, a light semi-crystalline thermoplastic biocompatible material, which has quite similar stiffness and strength to the bone (synthes® psi) was used.The following complications were reported: (case no.5) a case of a (b)(6)-year-old female had speech disturbances.The one-stage procedure lasted 375 min.Multiple dural suspensions worked to avoid epidural collection but at postoperative ct scan, multiple hemorrhagic foci and clinical course were characterized by aphasia that recovered in 3 months.(this patient is case no.5 in table 1).This report is for an unknown synthes psi.A copy of the literature article is being submitted with this medwatch.This is report 1 of 3 for (b)(4).

• Brand Name: UNK - PSI IMPLANTS
• Type of Device: PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11648236
• MDR Text Key: 244888734
• Report Number: 8030965-2021-02782
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK - PSI IMPLANTS: TRAUMA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - PLATES: TRUMATCH; UNK - SCREWS: TRUMATCH
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR