MAUDE Adverse Event Report: SYNTHES GMBH UNK - CAGE/SPACERS: T-PAL; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Device Problems Material Integrity Problem (2978); Patient Device Interaction Problem (4001)

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

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown t-pal cage/spacer/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.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.(b)(4).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: goertz l., et al (2020) impact of obesity on complication rates, clinical outcomes, and quality of life after minimally invasive transforaminal lumbar interbody fusion, journal of neurological surgery part- a volume 82, pages 147¿153 (germany).This retrospective, observational, single-center study aims to compare surgical complications, long-term pain outcome, and hrqol between obese and nonobese patients who underwent mistlif for degenerative spine disease.Between 2011 and 2014, 71 patients (50 females, 21 males) age 64.6-10.8 years underwent mis-tlif at a high volume tertiary care hospital.All patients were treated by the mis-tlif technique using polyaxial pedicle screws (viper 2 system, depuy synthes, raynham, massachusetts, united).The target disk was removed, and a peek cage (tpal, depuy synthes) filled with autologous bone chips was placed in the anterior third of the intervertebral space under fluoroscopic guidance.Follow-up duration (mo) 53.4 -12.8.The following complications were reported: 9 dural tears.1wound infection.1 rebleeding.Patients with postoperative neurological deficits (1 with a motor deficit, 1 with a sensory deficit, and 2 patients with a motor-sensory deficit).13 revision surgery.Cage migration and screw avulsion or breakage in 2 patients.Cage migration in 4 patients.This report is for an unknown depuy synthes peek cage (tpal).This is report 2 of 3 for (b)(4).Additional reports are captured under (b)(4).

• Brand Name: UNK - CAGE/SPACERS: T-PAL
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12314416
• MDR Text Key: 266255931
• Report Number: 8030965-2021-06610
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2021
• 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
• Date Manufacturer Received: 07/13/2021
• 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
• Patient Outcome(s): Required Intervention