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 Cerebrospinal Fluid Leakage (1772); Hematoma (1884); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This report is for an unk - screws: spine/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 as no product was received.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.Product was not returned.Based on the information available, it has been determined that no corrective and 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 (b)(6) as follows: this report is being filed after the review of the following journal article: jonkergouw j., et al (2016) outcome in patient-specific peek cranioplasty: a two-center cohort study of 40 implants, journal of cranio-maxillofacial surgery volume 44, pages 1266-1272 (netherlands).Http://dx.Doi.Org/10.1016/j.Jcms.2016.07.005.This retrospective study aims to evaluate patient- and surgery-related characteristics and risk factors that predispose patients to an increased risk of complications after peek cranioplasty.From 2011 to 2014, 38 consecutive patients (23 males, 15 females) with average age at peek cranioplasty was 43.2 ± 18.1 years (range 8e84) who underwent 40 peek cranioplasties in the academic medical center amsterdam (24 cranioplasties) and the st elisabeth hospital tilburg (16 cranioplasties).Peek implants used were (xilloc medical bv, maastricht, the netherlands, 29 cranioplasties; depuy synthes, zuchwil, switzerland, 7 cranioplasties; 3di gmbh, jena, germany, 4 cranioplasties).The median follow-up period was 19.1 months (iqr 12.5e30.6).The following complications were reported: 11 peek implants complications were seen in 11 patients.Complications consisted of infection (n=5), haematoma (n=4), csf leak (n=1) and wound-related problems (n=1).Five peek implants were removed due to infection.In three of these patients the same psi was reused after sterilization after 1.8, 3.8 and 8.0 months, without further complications.Two patients refused re-implantation and consequently a permanent loss of peek cranioplasty was seen in 5%.Ten cranioplasties (25%) required additional surgery.One patient with a postoperative (subgaleal) haematoma received conservative treatment, without the need for additional surgical intervention.Postoperative subcutaneous seroma formation was observed in four cases and resolved spontaneously in all.This report is for an unknown synthes peek implant.This report is for (1) unk - peek implant.This report is 1 of 1 (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: 11562738
• MDR Text Key: 242696769
• Report Number: 8030965-2021-02248
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 03/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2021
• 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: 03/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention