MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - VEPTR IMPLANTS: VEPTR II; PROSTHESIS, RIB REPLACEMENT

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

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.(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.(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.(b)(6)¿ 3 years post op implants revision surgery implant rods are out of length (b)(6) spinal fusion replaces rods- no failures reported.Concomitant device reported.Unk - screws (part# unknown, lot# unknown, qty24), unk - rod (part# unknown, lot# unknown, qty2).This complaint involves six (6) devices.This report is for (1) unk - veptr implants: veptr ii.This is report 1 of 6 or complaint (b)(4).

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.Reporter is a j&j representative.Investigation summary: the complaint device was not received for investigation.A photo investigation was performed based on the images received.The images were reviewed and the complaint condition is confirmed.The veptr device appears to have backed out of it's original placement several times and required multiple revision surgeries.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 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.

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.Reporter is a j&j representative.Investigation summary: the complaint device was not received for investigation.A photo investigation was performed based on the images received.The images were reviewed and the complaint condition is confirmed.The veptr device appears to have backed out of it's original placement several times and required multiple revision surgeries.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 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.(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.(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.(b)(6) ¿ 3 years post op implants revision surgery implant rods are out of length (b)(6) spinal fusion replaces rods- no failures reported.Concomitant device reported.Unk - screws (part# unknown, lot# unknown, qty24), unk - rod (part# unknown, lot# unknown, qty2).This complaint involves six (6) devices.This report is for (1) unk - veptr implants: veptr ii.This is report 1 of 6 or complaint (b)(4).

• Brand Name: UNK - VEPTR IMPLANTS: VEPTR II
• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12964358
• MDR Text Key: 286050981
• Report Number: 2939274-2021-06998
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/10/2021

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2021
• Initial Date FDA Received: 12/08/2021
• 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
• Treatment: UNK - RODS: LUMBAR SPINE; UNK - SCREWS: SPINE-US; UNK - VEPTR IMPLANTS: VEPTR II; UNK - VEPTR IMPLANTS: VEPTR II; UNK - VEPTR IMPLANTS: VEPTR II; UNK - VEPTR IMPLANTS: VEPTR II; UNK - VEPTR IMPLANTS: VEPTR II
• Patient Outcome(s): Required Intervention
• Patient Age: 3 YR