MAUDE Adverse Event Report: WRIGHTS LANE: SYNTHES USA PRODUCTS LLC 1.0MM TI T-PLATE 5 X 7 HOLES; PLATE, FIXATION, BONE

Model Number	420.71
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Eye Injury (1845)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information is unknown.It is unknown when the event occurred.This report is for a t-plate - unknown lot.Implant date: unknown.There is no indication that the device was removed.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.(b)(4).
Event or Problem Description
This report is being filed after subsequent review of the following article: tse, d: et al (2010) the use of titanium t-plate as platform for globe alignment in severe paralytic and restrictive strabismus.Am j ophthalmol, 150:404-411.(usa) this is a retrospective study to evaluate long-term effectiveness of improved ocular alignment using a suture/t-plate anchoring platform system.The suture/t-plate fixation (synthes craniofacial 1.0-mm module; synthes cmf, (b)(4)) was used to correct complex strabismus from january 2003 to december 2007.There were 6 women and 1 man with an average age of 55.7 years (range, 24¿79 years).The tip of the t-plate extends to the medial mid-orbit such that the shaft is situated below the frontoethmoidal suture line, away from the anterior and posterior ethmoidal arteries.For suture placement, a fornix-based medial conjunctival peritomy is made to delineate the medial rectus insertion.Six patients underwent between 1 and 3 strabismus surgeries and 4 patients received botulinum toxin type a injections to the antagonist muscle prior to suture t-plate placement.Only 1 patient did not have previous strabismus surgery or botulinum toxin injections.All 7 patients achieved single vision near the primary position.Single vision consisted of a limited field of single binocular vision in 4 cases and single monocular vision in 3 cases.Two patients developed an anomalous head position: a mild face turn in 1 patient (case 4) and an elevated chin posture attributable to bilateral limitation of upward gaze from oculomotor nuclear complex dysfunction in another (case 5).In patients with t-plate fixation medially, globe retraction was noted in 3 patients on abduction.No postoperative infections, suture breakage, or t-plate displacement were encountered.This is 1 of 2 for (b)(4).This report is for an unknown t-plate.Case 1, (b)(6) female experienced globe retraction.Case 4, (b)(6) male experienced anomalous head position (mild face turn).Case 5, (b)(6) female experienced anomalous head position (an elevated chin posture).Two unknown patient¿s experienced globe retraction.

• Brand Name: 1.0MM TI T-PLATE 5 X 7 HOLES
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE: SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7172107
• Report Number: 2939274-2018-50108
• Device Sequence Number: 1357237
• Product Code: HRS
• UDI-Device Identifier: 10887587049342
• UDI-Public: (01)10887587049342(10)UNKNOWNNUMBER
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K912932
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 12/11/2017

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
• Operator of Device: Health Professional
• Device Model Number: 420.71
• Device Catalogue Number: 420.71
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/11/2017
• Initial Report FDA Received Date: 01/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1