MAUDE Adverse Event Report: SYNTHES USA 3.5MM LCP PROXIMAL TIBIA PLATE LOW BEND 6 HOLES/102MM/LEFT; PLATE, FIXATION, BONE

Catalog Number 02.124.205

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

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).Exact date unknown; reported as approximately 1 year prior to explant date of (b)(6) 2016.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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 a hardware removal procedure was conducted on (b)(6) 2016, due to pain.The patient had a proximal tibia plate construct implanted approximately one (1) year ago.The patient had healed appropriately but presented with pain on an unknown date.The surgeon removed six (6) 3.5 mm locking screws, one (1) cortex screw, and one (1) 3.5 mm locking compression plate (lcp) lateral lowbend proximal 6-hole tibia plate.All devices were removed intact.There was no surgical delay or additional medical intervention required.The procedure was successfully completed and the patient status is stable.This is report 1 of 3 for (b)(4).

• Brand Name: 3.5MM LCP PROXIMAL TIBIA PLATE LOW BEND 6 HOLES/102MM/LEFT
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6210529
• MDR Text Key: 63430718
• Report Number: 2520274-2016-15784
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011978
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/02/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Weight: 105