MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - PEEK IMPLANT; PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE

Catalog Number UNK - PEEK IMPLANT

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

Patient Problem Impaired Healing (2378)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: 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.This report is for an unknown 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: lai jb, et al (2011), computer-assisted designed and computer-assisted manufactured polyetheretherketone prosthesis for complex fronto-orbito-temporal defect, j oral maxillofac surg, volume 69, pages 1175-1180, (usa).The purpose of this case presentation is to show the success to which the computer-assisted designed (cad) and computer-assisted manufactured (cam) polyetheretherketone (peek) prosthesis is used to reconstruct a traumatic fronto-orbito-temporal defect.A (b)(6) year-old caucasian male was referred for reconstruction of the left fronto-orbito-temporal defect measuring 109 cm2 after a motor vehicle collision about 2 months earlier.He underwent emergent left frontal craniotomy for the evacuation of the left frontal intracerebral hematoma and placement of left frontal ventriculostomy with a ventriculoperitoneal shunt.Due to the comminution of the fracture, the bones were unsalvageable for reconstruction.A preoperative high-resolution computed tomography (ct) was obtained and the images were then delivered to the manufacturer (synthes maxillofacial).A nonsterile prefabricated peek implant was delivered and sterilized at the hospital facility by heat sterilization.6 weeks later, the patient underwent surgery and was implanted with the unknown synthes peek optima-lt patient-specific implant.The implant was checked for fit and contoured using a high-speed competitor¿s drill with a cutting burr to accommodate the ventriculoperitoneal shunt.The implant was then secured with an unknown synthes 2.0-mm titanium miniplates and screws.Platelet-rich plasma was applied over the implant and surrounding areas before scalp closure to facilitate soft tissue healing.Symmetry of the fronto-orbito-temporal region with the uninjured side was achieved.The patient was followed for 6 months without wound dehiscence and other complications.At 7 months postop ration, the patient developed skin breakdown and fluid leakage over the left fronto-cranial implant due to over drainage from the left frontal ventriculoperitoneal low-pressure shunt.A ct without contrast showed over drainage of the ventriculoperitoneal shunt with fluid collection beneath the implant.Wound exploration, evacuation of the epidural fluid, and revision of the shunt with a medium-pressure valve proved successful.The patient did well and the skin healed uneventfully.This report is for the unknown synthes peek optima-lt patient-specific implant, unknown synthes 2.0-mm titanium miniplates and screws.This complaint involves three (3) devices.These impacted products capture the reported (b)(6) year-old male patient who developed skin breakdown and fluid leakage over the left fronto-cranial implant due to over drainage from the left frontal ventriculoperitoneal low-pressure shunt at 7 months postoperatively.This report is for one (1) unk - peek implant.This report is 1 of 3 for (b)(4).

• Brand Name: UNK - PEEK IMPLANT
• Type of Device: PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA
• MDR Report Key: 11671014
• MDR Text Key: 261247869
• Report Number: 2939274-2021-01849
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK - PEEK IMPLANT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2021
• 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
• Patient Age: 69 YR