WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - VEPTR IMPLANTS: VEPTR II; PROSTHESIS, RIB REPLACEMENT
|
Back to Search Results |
|
Device Problem
Patient Device Interaction Problem (4001)
|
Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
Event Type
Injury
|
Manufacturer Narrative
|
Product complaint (b)(4).This report is for an unk - veptr implants: veptr ii/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/ investigation.Reporter is a j&j representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 that on an unknown date, a case study by the physician where the veptr/veptr ii system failed several times and had to be removed from the patient after those failures.(b)(6).Reported l2 level myelomeningocele- progressing scoliosis 90 degrees 1 month post op failure 1 reported - implant moved out of position revision surgery #1 reseated right implant 1 rib lower 3 months later the device failed to remain seated and became infected - implants were removed 12 months post implant removal- the implants were revised to veptr2 1 month post op failure- proximal left cradle became disassembled- revision left rib cradle age (b)(6): 1 year post op- implants migrated out of position implants revision surgery reseated right rib cradle 9 months post op- implants migrated out of position revised right rib cradle and added a rib extension.Age (b)(6): 1 year post op- implants migrated out of position.Implants were removed and replaced with a halo traction method instead.(b)(6): reported high level myelomeningocele, trach dependent, g-tube, progressing scoliosis 90 degrees, poor sitting tolerance, and painful impingement and receives implant to correct.Age (b)(6)¿ 3 years post op implants revision surgery implant rods are out of length.Age (b)(6) spinal fusion replaces rods- no failures reported.Concomitant device reported.Unk - screws (part# unknown, lot# unknown, qty unk).Unk - rod (part# unknown, lot# unknown, qty unk).This complaint involves one (1) device.This report is for (1) unk - veptr implants: veptr ii.This is report 1 of 1 or complaint (b)(4).
|
|
Manufacturer Narrative
|
Product complaint #(b)(4).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.H10 additional narrative: h3; h: investigation summary: the complaint device was not received for investigation.A photo investigation was performed based on the images was received.The images were reviewed and the complaint condition is not confirmed.The case involving the 5 year old is a planned revision surgery due to the design of the veptr ii implant system.The doctor reported no device/fixation failures and the veptr ii implant system was exchanged for spinal fusion.There does not appear to be any visual defects or damage that would contribute to the complaint condition in the x-rays provided.A definitive assignable root cause could not be determined based on the provided information.No valid lot number was provided or found in the photos, therefore no dhr review was completed.The dhr review will be revisited if a valid lot number is provided or the physical device is received.As the device was not returned, an as-received condition could not be assessed and a dimensional inspection and document/specification review were not completed.During the investigation, no product design issues or discrepancies were observed (based on the image) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot no valid lot number was provided or found in the photos, therefore no dhr review was completed.The dhr review will be revisited if a valid lot number is provided or the physical device is 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.
|
|
Search Alerts/Recalls
|
|
|