MAUDE Adverse Event Report: SYNTHES USA; PLATE, FIXATION, BONE

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

Patient Problems Rash (2033); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.It is unknown when reaction began; hives showed up approximately 2 months post-operatively.This report is for one (1) unknown device plate (other number-udi)no part number, udi unavailable device remains implanted in the patient.Device is unavailable for return.Therapy date for concomitant device unknown.Part # is unknown, 510k number is unknown.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 a patient is experiencing localized and generalized hives, which is suspected to be related to a metals allergy.The patient underwent a tibia/fibula repair on (b)(6) 2016, involving the implantation of one fibula plate and seven screws, and also one tibia screw.The hives began approximately two months postoperatively.The patient also underwent a breast biopsy in (b)(6) 2016, during which a titanium marker was placed.The patient has recently been treated with steroids.She stated that presently the symptoms are returning.The patient's allergist is seeking metal samples for skin patch testing.Concomitant devices: breast biopsy titanium marker/clip (part #unknown, lot #unknown, quantity 1) this report is for one (1) unknown plate.This is report 1 of 3 for com-(b)(4).

• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6151216
• MDR Text Key: 61632260
• Report Number: 2520274-2016-15608
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 11/15/2016

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/15/2016
• Initial Date FDA Received: 12/07/2016
• 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: BREAST BIOPSY TITANIUM MARKER (PART/LOT UNK QTY 1)
• Patient Outcome(s): Required Intervention
• Patient Weight: 77