MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ONE-THIRD TUBULAR PLATE WITH COLLAR 7 HOLES/85MM; PLATE, FIXATION, BONE

Model Number 241.37

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

It was reported that on unknown date, a patient had full body rash which began after an ankle fracture repair with one (1) 3.5 mm lcp one-third tubular plate and eight (8) 3.5 mm cortex screws.Allergy testing has confirmed the patient is allergic to indium (iii) chloride, a compound found in some metal alloys which maybe of the implants.No further information provided.This report is for one (1) one-third tubular plate with collar 7 holes/85mm.This is report 1 of 9 for complaint (b)(4).

• Brand Name: ONE-THIRD TUBULAR PLATE WITH COLLAR 7 HOLES/85MM
• Type of Device: PLATE, FIXATION, BONE
• 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: 13793126
• MDR Text Key: 287352599
• Report Number: 2939274-2022-00901
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982166883
• UDI-Public: (01)10886982166883
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 241.37
• Device Catalogue Number: 241.37
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2022
• Initial Date FDA Received: 03/17/2022
• 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: 3.5 CRTX SCR LOW PROF HD STPING/SD/10; 3.5 CRTX SCR LOW PROF HD STPING/SD/12; 3.5 CRTX SCR LOW PROF HD STPING/SD/14; 3.5 CRTX SCR LOW PROF HD STPING/SD/18; 3.5 CRTX SCR LOW PROF HD STPING/SD/20; 3.5MM CORTEX SCREW SELF-TAPPING 28MM; 3.5MM CORTEX SCREW SELF-TAPPING 75MM; 3.5MM CORTEX SCREW SELF-TAPPING 75MM
• Patient Outcome(s): Required Intervention