MAUDE Adverse Event Report: SYNTHES GMBH UNK - BIOMATERIAL - CEMENT: VERTECEM; POLYMETHYLMETHACRYLATE BONE CEMENT

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Cerebrospinal Fluid Leakage (1772); Hematoma (1884); Failure of Implant (1924); Nerve Damage (1979); Decreased Sensitivity (2683); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown cement/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes 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.(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 a clinical evaluation report (cer) from a related research activity database (ddra) for patients undergoing spinal decompression/fusion.Failed spinal decompression/fusion has been identified as the reported complication as per spine tango registry report experienced by the following with corresponding intervention: 10 patients had general complications - intraoperative: anaesthesiological (2), cardiovascular (1), pulmonary (1), death (1), other (2), not documented (3).73 patients had general complications - postoperative surgical before discharge: cardiovascular (9), pulmonary (9), cerebral (5), kidney/urinary (9), liver/gi (4), thromboembolism (1), death (3), other (5), not documented (27), and unknown (1).27 patients had surgical complications - intraoperative adverse events: nerve root damage (1), dural lesion (10), other (16).52 patients had surgical complications - postoperative surgical before discharge: epidural hematoma (1), other hematoma (1), radiculopathy (2), csf leak/pseudomeningocele (1), motor dysfunction (6), sensory dysfunction (3), wound infection superficial (2), wound infection deep (2), implant failure (1), other (7), not documented (25), and unknown (1).116 patients had reoperations at any level due to adjacent segment pathology (18), failure to reach therapeutic goals (10), hardware removal (9), implant failure (5), implant malposition (2), instability (18), neurocompression (12), non-union (6), other (20), postoperative infection deep (10), postoperative infection superficial (2), sagittal imbalance (3), and unknown (75).22 patients had reoperations at the same level due to adjacent segment pathology (5), failure to reach therapeutic goals (4), hardware removal (2), implant failure (1), implant malposition (1), instability (5), neurocompression (8), non-union (1), other (10), postoperative infection deep (5), postoperative infection superficial (2), sagittal imbalance (1), and unknown (5).This is for depuy synthes spine vertecem.This report is for one (1) unknown cement.This is report 4 of 5 for (b)(4).

• Brand Name: UNK - BIOMATERIAL - CEMENT: VERTECEM
• Type of Device: POLYMETHYLMETHACRYLATE BONE CEMENT
• 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: 11214296
• MDR Text Key: 228618179
• Report Number: 8030965-2021-00515
• Device Sequence Number: 1
• Product Code: NDN
• 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
• Type of Report: Initial
• Report Date: 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• 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: 12/29/2020
• 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