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

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

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Multiple patients involved.Implantation date unknown.This report is for an unk - psi implants/unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(b)(4).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

Device report from synthes reports an event in (b)(6) as follows: 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-maxillofacial 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 desaturation 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 is report 2 of 5 for (b)(4).Related product complaint: (b)(4).

• Brand Name: UNK - PSI IMPLANTS
• Type of Device: PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10357673
• MDR Text Key: 203292497
• Report Number: 8030965-2020-05560
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• Reporter Country Code: FI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2020
• 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: 07/27/2020
• 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