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

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Bone Fracture(s) (1870); Nerve Damage (1979); Osteolysis (2377); Decreased Sensitivity (2683); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

This report is for an unk - biomaterial - cement: vertecem/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is jnj representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(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

Device report from synthes reports an event in switzerland as follows: this report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (ddra) to compare usage and outcomes recorded in 87 patients (32 males, 55 females) for vbs implants against all other surgical cases recorded within the spine tango registry between 2004 and the specified date.Final registry report outcome description: general complications- postoperative surgical before discharge.1 cerebral.1 death.Surgical complications- intraoperative adverse events.2 other.Surgical complications- postoperative surgical before discharge 1 radiculopathy.1 motor dysfunction.1 sensory dysfunction.Reoperations : number of reoperations at any level (9).1 failure to reach therapeutic goals.1 hardware removal.1 implant failure.1 instability.7 unknown.This is for depuy synthes vertecem cement.It captures the reported events of 1 hardware removal, 1 implant failure and 1 instability.This is report 3 of 6 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10: additional narrative: b5 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

Updated event description: this report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (ddra) to compare usage and outcomes recorded in 183 patients (60 males, 126 females) for vbs implants against all other surgical cases recorded within the spine tango registry between 2012 to 2023.The following complications were reported: intra-operative general complications 1 anaesthesiological intra-operative surgical complications 3 other post-operative general complications before discharge 1 cerebral 1 death post-operative surgical complications before discharge 1 radiculopathy 1 motor dysfunction 1 sensory dysfunction postoperative complications 1 sensory dysfunction 1 motor dysfunction 2 adjac.Segment pathology 3 fracture vertebral structures 1 other reoperations: 12 reoperations at any level 1 hardware removal 1 instability 1 failure to reach therapeutic goals 1 implant failure 1 neurocompression 10 unknown 5 reoperations at an adjacent level 1 hardware removal 1 instability 1 failure to reach therapeutic goals 1 implant failure 1 neurocompression 3 unknown 2 reoperations at the same level 1 hardware removal 1 instability 1 failure to reach therapeutic goals 1 implant failure 1 unknown.

• 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 ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 11212678
• MDR Text Key: 231351108
• Report Number: 8030965-2021-00513
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/28/2020

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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention