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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; PROSTHESIS, RIB REPLACEMENT
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WRIGHTS LANE SYNTHES USA PRODUCTS LLC; PROSTHESIS, RIB REPLACEMENT Back to Search Results
Device Problem Migration (4003)
Patient Problems Failure of Implant (1924); No Code Available (3191)
Event Date 09/07/2018
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown constructs: veptr/unknown lot number.Without the specific part number, the udi number and 510k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).This impacted product captures the following adverse event: -device migration, revised without a lot number, the device history records review could not be completed as no product was received.Investigation summary: the investigation could not be completed; no conclusion could be drawn at the time of filing this report.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.
 
Event Description
This report is being filed after the review of the following journal article: eby sf.Et al (2018), thoracogenic spinal deformity: a rare cause of early-onset scoliosis, j neurosurg spine, volume 29, pages 674-679, (usa).The purpose of this study was to evaluate and characterize patients with severe thoracogenic scoliosis from a large, multicenter database of children with early-onset scoliosis (prior to 10 years of age).Between 2002 and 2014, 41 patients who underwent a prior medical procedure or surgery on the chest wall or spine (sternotomy, thoracotomy, chest wall resection, laminectomy, or chest wall radiation therapy) and were noted to have thoracogenic scoliosis were included in the study.Of the 41 patients, 14 were observed, 10 received casts and/or braces, and 17 were treated surgically.There were 15 patients who underwent treatment using an unknown synthes vertical expandable prosthetic titanium rib (veptr), 1 underwent a shilla procedure, and 1 had growing rods implanted.All operative patients had bilateral devices placed.The operative patients included 6 males and 9 females with a mean age at scoliosis surgery of 6.6 years and a mean of 4.5 years of follow-up.Over the study period, patients underwent a mean of 7.5 surgeries (range 2¿21), including a mean of 4.75 lengthening procedures (range 0¿14).13 complications occurred in 7 patients implanted with the veptr device including the following: 5 patients had pneumonia in which 3 of them required hospitalization while the other 2 were treated on an outpatient basis.1 patient had brachial plexus palsy that was resolved with revision of the rib hooks.3 patients had a spine infection and required revision.1 patient had device migration and required revision.1 patient had implant failure 3 times and required revision.This report is for one (1) device- unknown synthes vertical expandable prosthetic titanium rib (veptr).This impacted product captures the following adverse event: device migration, revised.This is report 1 of 2 for (b)(4).
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.
 
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Type of Device
PROSTHESIS, RIB REPLACEMENT
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
MDR Report Key8742301
MDR Text Key149480317
Report Number2939274-2019-58905
Device Sequence Number1
Product Code MDI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,litera
Type of Report Initial,Followup
Report Date 06/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received06/28/2019
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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