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

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

Patient Problems Bone Fracture(s) (1870); Nerve Damage (1979); Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

His report is for an unknown t-pal cage/spacers/unknown lot.Part and lot number are unknown; udi number is unknown.Implant date is between (b)(6) 2011 and (b)(6) 2021.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.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 a clinical evaluation report (cer) from a related research activity database (ddra) for patients undergoing spinal decompression, fusion, and stabilisation.Failed spinal decompression, fusion, and stabilisation has been identified as the reported complication as per spine tango registry report experienced by the following with corresponding intervention: 4 patients had general complications - intraoperative: anaesthesiological (1), other (1), not documented (2).18 patients had general complications - postoperative surgical before discharge: cardiovascular (2), pulmonary (2), cerebral (1), thromboembolism (1), other (3), not documented (9).43 patients had surgical complications - intraoperative adverse events: nerve root damage (3), dural lesion (36), vascular injury (1), fracture vertebral structures (1), other (2).42 patients had surgical complications - postoperative surgical before discharge: epidural hematoma (6), other hematoma (2), radiculopathy (4), csf leak / pseudomeningocele (3), motor dysfunction (5), sensory dysfunction (3), bowel / bladder dysfunction (2), wound infection superficial (2), wound infection deep (3), implant malposition (3), implant failure (1), other (2), not documented (6).96 patients had reoperations: at any level due to adjacent segment pathology (28), failure to reach therapeutic goals (7), hardware removal (15), implant failure (17), implant malposition (7), instability (14), neurocompression (8), non-union (20), other (8), postoperative infection deep (11), postoperative infection superficial (4), sagittal imbalance (8), unknown (21); and at same level due to adjacent segment pathology (7), failure to reach therapeutic goals (3), hardware removal (6), implant failure (10), implant malposition (4), instability (3), neurocompression (5), non-union (14), other (6), postoperative infection deep (6), postoperative infection superficial (4), sagittal imbalance (4), unknown (2).This is for depuy synthes t-pal cage.This report is for one (1) unknown t-pal cage/spacers.This is report 3 of 3 for (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: 11807581
• MDR Text Key: 264769603
• Report Number: 8030965-2021-03832
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/03/2021

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/03/2021
• Initial Date FDA Received: 05/11/2021
• 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