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U.S. Department of Health and Human Services

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

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SYNTHES GMBH UNK - SYNFLATE/VBS; POLYMETHYLMETHACRYLATE BONE CEMENT Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bone Fracture(s) (1870); 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.H10 additional narrative: g4-510k: this report is for an unknown synflate/vbs: synflate/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j employee.H6: 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 (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 3 of 4 for (b)(4).
 
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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 Key18911940
MDR Text Key337749717
Report Number8030965-2024-03692
Device Sequence Number1
Product Code NDN
Combination Product (y/n)N
Reporter Country CodeSZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Study,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
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 03/11/2024
Initial Date FDA Received03/15/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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