MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - CAGE/SPACERS: T-PAL; INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR

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

Patient Problems Nerve Damage (1979); Pain (1994); Non-union Bone Fracture (2369); Osteolysis (2377); Post Operative Wound Infection (2446); Unspecified Tissue Injury (4559)

Event Type  Injury  

Event Description

This report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (drra) for 2,057 patients who were treated with t-pal peek (n=404) and t-pal other (ti: n=39; unspecified material: n=1,614) during surgical procedures of the lumbar or lumbosacral spine between january 1, 2010 and june 30, 2020.The study cohort included more females (55%) than males (45%) with a mean age of 58.3 years (sd=12.6).Reported complication as per icd 9 & 10 categorization experienced by the following with corresponding intervention: 18 patients (peek=3; other=15) had a reoperation within 0-3 months following the index procedure for surgeries (excluding fusion, decompression, or device removal) in any region of the lumbar or lumbosacral spine and with a diagnosis of wound complication (seroma and hematoma), infection, or dural tear.36 patients (peek= 11; other=25) had a revision within 0-3 months following the index procedure for fusion, decompression, or device removal, and a diagnosis indicating the presence of degenerative spine diseases, nonunion/pseudarthrosis, back pain, radiculopathy, myelopathy, or device-related complication.90 patients (peek=22; other=68) had a revision within 0-12 months following the index procedure for fusion, decompression, or device removal, and a diagnosis indicating the presence of degenerative spine diseases, nonunion/pseudarthrosis, back pain, radiculopathy, myelopathy, or device-related complication.52 patients (peek=7; other=45) had a revision within 13-24 months following the index procedure for fusion, decompression, or device removal, and a diagnosis indicating the presence of degenerative spine diseases, nonunion/pseudarthrosis, back pain, radiculopathy, myelopathy, or device-related complication.This is for an unknown depuy synthes t-pal interbody system (including ti, peek, and unspecified material).This is report 1 of 1 for (b)(4).

Manufacturer Narrative

If the information is unknown, not available or does not apply, the section/field of the form is left blank.Pma/510k: this report is for an unknown t-pal interbody system/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.Reporter is a j&j employee.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.

• Brand Name: UNK - CAGE/SPACERS: T-PAL
• Type of Device: INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 14047479
• MDR Text Key: 290461078
• Report Number: 2939274-2022-01227
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/09/2022
• 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