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

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

Patient Problems Unspecified Infection (1930); Pain (1994); Reaction (2414); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown plates/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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: becker, c.E., keeler, k.A., kruse, r.W., shah, s.A.(1999), complications of blade plate removal, journal of pediatric orthopaedics, vol.19 (2), pages 188-193 (usa).The aim of this retrospective study is to show that removal of the blade plate was a relatively safe procedure in those patients troubled by prominent/painful hardware or skin breakdown.Between january 1990 to june 1997, a total of 229 children (121 boys and 108 girls) had removal of one or two blade plates, with a total of 244 procedures and 426 blade plates removed.The ao fixed-angle blade plate (synthes, paoli, pa, u.S.A.) has been used in children for fixation of proximal femoral osteotomy.The average follow-up was 31 months (range: i-93 months).The average age at the time of the initial procedure was 9 years 5 months (range: 2-19 years 10 months).The mean time to blade-plate removal was 17 months (range: 2-74 months).The average age at blade-plate removal was l0 years l0 month (range: 2 years 11 months-20 years 11 months).The following complications were reported as follows: patient 1 had a proximal femur fracture right side which occurred at the time of plate removal.Patient 2 had a proximal femur fracture left side occurred 1 day after the child¿s bilateral plate removal.Patient 3 had a femoral neck fracture left side occurred 12 weeks after his blade plate was removed, which was thought that the seizure caused his left femoral neck to fracture through a portion that may have been weakened by the recent blade-plate removal.The indications for blade-plate removal were prominent/painful hardware in 74%, skin breakdown/infection in 13%, and unspecified in 13 percent.This report captures the reported events of prominent/painful hardware in 74 percent, skin breakdown/infection in 13 percent, unspecified in 13 percent.This report is for an unknown synthes plates.This is report 7 of 8 for (b)(4).

• 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: 8599900
• MDR Text Key: 144710656
• Report Number: 2939274-2019-57953
• 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: 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2019
• 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: 04/12/2019
• 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