MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - PLATES; PLATE, FIXATION, BONE

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

Patient Problem Nerve Damage (1979)

Event Type  Injury  

Manufacturer Narrative

A total of 23 patients (18 males and 5 females) with a mean age of 35.3 years (range 17-63) were included in this study.This report is for an unknown 4.5mm narrow dynamic compression plate/unknown lot.Part and lot number are unknown; udi number is unknown.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

This report is being filed after the review of the following journal article: routt, m.L.Et.Al.(1996), internal fixation in pelvic fractures and primary repairs of associated genitourinary disruptions: a team approach, the journal of trauma: injury, infection, and critical care, vol.40(5), pages 784-790 (usa).10.1097/00005373-199605000-00018.This study describes a treatment protocol and reports the early results of 23 patients with unstable pelvic fractures and associated bladder or urethral disruptions, or both, treated surgically with open reduction and internal fixation of the anterior pelvic ring injuries at the same anesthetic and using the same surgical exposure as the urethral realignments or bladder repairs, or both.A total of 23 patients (18 males and 5 females) with a mean age of 35.3 years (range 17-63) were included in this study.17 patients had anterior pelvic stabilizations, after open reductions, using single 3.5-mm reconstruction plates (synthes, inc., paoli, pa.) of variable lengths dependent upon the injury patterns.5 patients had 2-hole 4.5-mm narrow dynamic compression plates (synthes, inc., paoli, pa) used for symphyseal fixation.Follow-up examinations were available for all the patients and ranged from 3 to 36 months with a mean of 15.5 months.The following complications were reported as follows: 2 of 3 male patients admitted to impotence.Additional devices for this article are captured on related complaints (b)(4).This report is for an unknown 4.5mm narrow dynamic compression plate.This is report 5 of 10 for (b)(4).

• Brand Name: UNK - PLATES
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8888656
• MDR Text Key: 154149610
• Report Number: 2939274-2019-59796
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2019
• 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