MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PSI SD800.401 PEEK IMPLANT; PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE

Catalog Number SD800.401

Device Problem Defective Device (2588)

Patient Problems Failure of Implant (1924); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

There are multiple patients all information is provided in the article.Implant date is between june of 2013 to november of 2018.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: jarvinen, s.Et al (2019), the use of patient specific polyetheretherketone implants for reconstruction of maxillofacial deformities, journal of cranio-maxillo-facial surgery, vol.47 (7), pages 1072-1076 (finland).The aim of this retrospective study is to evaluate polyetheretherketone (peek) as a patient-specific implant (psi) material in maxillofacial reconstructive surgery.Between june of 2013 to november of 2018, a total of 24 patients (9 male and 15 female) with a mean age of 30.8 years (range, 16-71 years) underwent maxillofacial surgery using peek patient-specific implants (psis).Surgery was performed using psi manufactured by depuy synthes, switzerland in 2 patients and 22 by a competitor.The peek psis were then fixed to the surrounding bone with matrix midface or matrix orthognathic titanium screws (depuy synthes).The average follow-up period was 16.2 months (range, 2-63 months).The following complications were reported as follows: in a (b)(6) year old female patient, the psi did not fit well onto the underlying bone and was trimmed.A (b)(6) year old female patient had a wound dehiscence that did not show any clear marks of infection, even though the implant was exposed intraorally, and the patient was followed up for over 10 months after surgery.After 10 months of follow-up, the implant at the angle of the mandible was still exposed at the superior and anterior border of the ramus, and the patient underwent a second surgical procedure in which the psi was trimmed to become lower and smoother buccally.The wound healed well after the implant modification, but an intraoral fistula re-occurred without evidence of clinical infection.Because of the fistula, the patient underwent yet another surgical procedure in which the fistula was removed, and granulation tissue was purified around the psi.A (b)(6) year old female patient had minor paresthesia.A reoperation was needed at 9 months after the first operation due to major weight loss that led to the asymmetry of mandibular body becoming clinically visible.The implant correcting the defect of the mandibular symphysis area was replaced with two new implants that corrected the asymmetry more widely.A (b)(6) year old male patient had minor paresthesia.A (b)(6) year old female patient had minor paresthesia.A (b)(6) year old female patient had minor paresthesia.A (b)(6) year old male patient experienced a transient facial paralysis of the zygomatic branch of the facial nerve that occurred 2 weeks after surgery and that was probably caused by postoperative swelling.A (b)(6) year old male patient had wound dehiscence that was clinically infected and was treated with resuturation and antibiotics 20 days after surgery (early infection, defined as occurrence between weeks 0 and 4 postoperatively in this study).A (b)(6) year old male patient had minor paresthesia.A (b)(6) year old male patient had minor paresthesia.This report is for an unknown synthes psi implants and unknown synthes screws.This report is for one (1) psi sd800.401 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.The device was not returned.The investigation was performed by product development (pd).Design review this impacted product captures the reported 46-year-old female patient whose psi did not fit well onto the underlying bone and was trimmed.Based on the available information from the publication and the synthes data base the case could be attributed to the synthes case id: (b)(6).The case design represents a two (2) piece design which result into the following article and lot numbers: psi article 1: sd800.401; psi lot number 1: 8980250, psi article 2: sd800.401; psi lot number 2: 8980259.The document review performed on the available order and image approval which state that the design of the implant was generated by an external source and was provided to synthes as an stl file for manufacturing only.The synthes psi team were not provided with patient ct data and no alterations were made to the implant design, therefore synthes takes no responsibility for the planning of the design.Since synthes did not contributed to the design of the device this non-manufacturing design investigation is closed by the trumatch product development as a not valid complaint for which synthes is responsible because the design was provided by the requesting surgeon to synthes.Conclusion the complaint was not confirmed during investigation.There were no issues during the manufacture of this product that would contribute to this complaint condition.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.Device history lot part: sd800.401, lot: 8980259, manufacturing site: mezzovico, release to warehouse date: may 12, 2014.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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 SD800.401 PEEK IMPLANT
• Type of Device: PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10375027
• MDR Text Key: 209179020
• Report Number: 8030965-2020-05714
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• PMA/PMN Number: K053199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SD800.401
• Device Lot Number: 8980259
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/02/2020
• Patient Sequence Number: 1
• Patient Age: 46 YR