MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI MATRIXMIDFACE ADAPTION PLATE/20 HOLES/0.7MM THICK; BONE PLATE

Model Number 04.503.376

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

Patient Problems Swelling (2091); Weakness (2145)

Event Type  Injury  

Manufacturer Narrative

Additional code: dzl.Complainant part is not expected to be returned for manufacturer review/investigation.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.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

It was reported that on an unknown date, the patient underwent an acoustic neuroma resection retrosigmoid procedure.Patient was implanted with an unknown bone plates and putty cement.Postoperatively, the patient's surgery was complicated by swelling of the neck which required the patient to be kept intubated for an extra two days for airway protection.The patient's shoulder was mildly weak after the surgery and was attributed to brachial plexus stretch injury.The patient is making good progress and the post operative complications were resolved.Patient's outcome is unknown.This is report 2 of 3 for (b)(4).

• Brand Name: TI MATRIXMIDFACE ADAPTION PLATE/20 HOLES/0.7MM THICK
• Type of Device: BONE PLATE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10420805
• MDR Text Key: 203357689
• Report Number: 2939274-2020-03601
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 10887587020198
• UDI-Public: (01)10887587020198
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083388
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 04.503.376
• Device Catalogue Number: 04.503.376
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2020
• 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
• Treatment: CRANIOS REINFORCED FAST SET PUTTY 3CC-S; UNK - SCREWS: MATRIXMIDFACE
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR