MAUDE Adverse Event Report: SYNTHES GMBH UNK - PSI IMPLANTS; BONE PLATE

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

Patient Problem Nerve Damage (1979)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown psi implants: trauma/unknown lot.Part and lot numbers 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

Device report from synthes reports an event in the (b)(6) as follows: this report is being filed after the review of the following journal article: anabtawi m, thomas m, and lee nj (2021), the use of interlocking polyetheretherketone (peek) patient-specific facial implants in the treatment of facial deformities.A retrospective review of ten patients, journal of oral and maxillofacial surgery, vol.79 (xx), pages 1145.E1-1145.E9 (united kingdom).This retrospective study aims to present our experience in the use of interlocking peek patient-specific implants (psis) in different areas of the face.A total of 10 patients (6 male and 4 female) with a mean age of 34.8 years (range 17-54 years) were included in the study.Surgery was performed using peek patient-specific implants (psi; depuy synthes, oberdorf, switzerland) fixed with 2, matrixmidface or matrixmandible titanium, screws (depuy synthes); however, if the implant had an excellent fitting surface, 1 screw could suffice.2 patients had mandibular psis in combination with a centralizing/rotation genioplasty using a titanium patient-specific guide and patient-specific plate (materialise, leuven, belgium).The mean follow-up period was 37.1 months (range 11 to 61 months).The following complications were reported as follows: a (b)(6) year-old male patient (with 2 psi implanted) developed recurrent right maxillary sinus infection manifested by facial swelling but no signs of infection around the implant.A ct scan showed an entirely obliterated maxillary sinus with a fixation screw protruding into the sinus cavity.After a referral to ear, nose, and throat surgery, the patient was treated successfully with functional endoscopic sinus surgery, the implant remained in situ, and no further complications 3 years after functional endoscopic sinus surgery.A (b)(6) year-old female patient (with 2 psi implanted) had residual subcutaneous swelling over her right zygoma.A (b)(6) year-old male patient (with 3 psi implanted) had bilateral altered sensation in the distribution of the mental nerve with a 3-part mandibular implant.This report is for an unknown synthes psi implants.This is report 6 of 14 for (b)(4).

• Brand Name: UNK - PSI IMPLANTS
• Type of Device: BONE PLATE
• 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: 12353462
• MDR Text Key: 267661644
• Report Number: 8030965-2021-07044
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 21 YR