MAUDE Adverse Event Report: SYNTHES GMBH UNK - SYNFLATE/VBS; POLYMETHYLMETHACRYLATE BONE CEMENT

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

Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369); Osteolysis (2377); Impaired Healing (2378); Spinal Cord Injury (2432); Post Operative Wound Infection (2446); Ambulation Difficulties (2544); Decreased Sensitivity (2683); Vertebral Fracture (4520); Joint Laxity (4526); Physical Asymmetry (4573); Insufficient Information (4580)

Event Type  Injury  

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.This report is for an unknown synflate/vbs/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter occupation: 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.

Event Description

Device report from synthes reports an event in switzerland as follows: this report filled after the review of a clinical evaluation report(cer)from a related research activity database(drra): spine tango implant report ¿ synflate between march 22, 2013 and may 25, 2022, with a total of 79 patients (79 procedures; 27 male and 52 female; mean age of 69.7 years) who were operated with depuy synthes spine synflate.The following complications have been identified: intraoperative surgical complications: 1 patient had other complications.General complications-postoperative 1 patient had kidney/urinary.Postoperative complications: 1 patient had sensory dysfunction.1 patient had wound infection deep.1 patient had adjacent segment pathology.1 patient had bowel/bladder dysfunction.1 patient had non-union.1 patient had implant failure.1 patient had instability.1 patient had implant malposition.2 patients had adjacent.Segment disease.3 patients had fractured vertebral structure.4 patients had other complications.Reoperations: 19 patients had reoperation at any level.6 patients had reoperation at an adjacent level.4 patients had reoperations at same level.1 patient had reoperation due to adjacent segment pathology.1 patient had reoperation due to failure to reach therapeutic goals.1 patient had reoperation due to hardware removal.1 patient had reoperation due to instability.3 patients had reoperation due to neurocompression.1 patient had reoperation due to non-union.1 patient had reoperation due to other complications.2 patients had reoperation due to sagittal imbalance.12 patients had reoperation due to unknown complications.This is for unknown depuy synthes spine synflate.This is report 1 of 1 for (b)(4).

Event Description

Device report from synthes reports an event in switzerland as follows: this report filled after the review of a clinical evaluation report (cer)from a related research activity database (drra): spine tango implant report ¿ synflate between (b)(6) 2013 and (b)(6) 2024, with a total of 202 patients (211 procedures; 77 male and 134 female; mean age of 74.8 years) who were operated with depuy synthes spine synflate.The following complications have been identified: intraoperative general complications: (n=1) other postoperative general complications before discharge: (n=2) kidney / urinary.(n=1) other.Intraoperative surgical complications: (n=1) other.Postoperative surgical complications before discharge: (n=1) other.Surgery follow-up complications early (< 28 days): (n=1) bowel/ bladder dysfunction.(n=1) fractured vertebral structures.(n=2) other.Sub-acute (2-6 months): (n=1) adjacent segment pathology.(n=2) fractured vertebral structures.(n=1) implant failure.(n=1) implant malposition.(n=1) instability.Late (> 6 months): (n=1) other.Reoperations at any level (n=25) due to: (n=1) non-union.(n=2) sagittal imbalance.(n=2) instability.(n=3) neurocompression.(n=1) failure to reach therapeutic goals.(n=1) adjacent segment pathology.(n=1) hardware removal.(n=1) other.(n=17) unknown complications.Reoperations at an adjacent level (n=11): (n=1) non-union.(n=1) instability.(n=1) neurocompression.(n=1) hardware removal.(n=7) unknown complications.Reoperations at the same level (n=7): (n=1) non-union.(n=1) sagittal imbalance.(n=2) instability.(n=2) neurocompression.(n=1) failure to reach therapeutic goals.(n=1) adjacent segment pathology.(n=1) other.(n=2) unknown complications.This is for unknown depuy synthes spine synflate.This is report 1 of 4 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.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 - SYNFLATE/VBS
• Type of Device: POLYMETHYLMETHACRYLATE BONE CEMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15542706
• MDR Text Key: 301167119
• Report Number: 8030965-2022-07868
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/11/2024
• 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