MAUDE Adverse Event Report: SYNTHES GMBH UNK - PEEK IMPLANT; PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE

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

Patient Problems Hematoma (1884); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

This report is for an unk - peek implant/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

This report is being filed after the review of the following journal article: zhang, q.Et al (2018), a large multicenter retrospective research on embedded cranioplasty and covered cranioplasty, world neurosurgery, vol.112 (xx), pages e645-e651 (china).The aim of this multicenter retrospective cohort study is to compare the clinical outcomes and complications of embedded cp and covered cp.Between january 2014 to march 2017, a total of 185 patients were included in the study.Surgery was performed using peek implants depuy synthes, (b)(4) and competitor; peek group in 75 patients (62 male and 13 female) with a mean age of 33.27 ¿ 14.26 years, while titanium implant from competitor (titanium group) in 110 patients (82 male and 28 female) with a mean age of 37.57 ¿ 15.41 years.The mean follow-up duration of peek group and titanium group is 13.5 ¿ 4.9 months and 14.2 ¿ 6.9 months, respectively.The following complications were reported as follows: peek group: the rate of overall complications is 13 (17.3%).6 patients had subgaleal effusion.Of these 6 patients, 5 were cured by wrapping their heads in elastic bandages after having the fluid drawn out with a syringe.Having tried this method several times on the sixth patient, the refractory subgaleal effusion was still not cured.Eventually, the situation was improved after we performed lumbar drainage.Unfortunately, this patient subsequently acquired severe surgical site infections, and the ineffectiveness of antibiotics left us with no choice but to remove the implants.Another patient with the same subgaleal effusion was cured by the intravenous infusion of antibiotics.1 patient had postoperative epidural hematoma because of postoperative low platelets in her blood.After communicating with her family members, they decided not to allow us to perform hematoma evacuation surgery.This patient was eventually cured with conservative therapy.2 patients had surgical site infections.3 patients had postoperative new seizures.3 patients had postoperative hematoma.1 patient had implant exposure.1 patient underwent reoperation.4 patients had poor outcome.56 patients had no brain function improvement.In 5 out of 10 patients, the seizure did not disappear.This report is for one (1) an unknown synthes peek implant.This is report 1 of 1 for complaint (b)(4).

• Brand Name: UNK - PEEK IMPLANT
• 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: 11680631
• MDR Text Key: 245988609
• Report Number: 8030965-2021-03006
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2021
• 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: 03/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1