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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - SCREWS: SPINE-US; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
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SYNTHES GMBH UNK - SCREWS: SPINE-US; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD Back to Search Results
Device Problem Material Integrity Problem (2978)
Patient Problem 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.D1, d2, d3, d4, g4-510k: this report is for an unknown spine screw/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.H3, h4, h6: without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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: a real-world analysis to evaluate the clinical outcomes of patients requiring anterior reconstruction of the cervical, thoracic, or lumbar spine with the synmesh cage.Analysis years were from 2017 ¿ 2020.Adverse events were as follows: 34 incidences of neurological defict, 8 instances of infection, 8 instances of loss of fixation, 8 instances of nonunion, 6 instances of cardiovascular complication, 4 instances of proximal junctional kyphosis, 3 incidences of wound dehiscence, 2 instances of vascular complications, 2 incidences of pulmonary complications, 2 incidences of adjacent compression fracture, 2 incidences of adjacent segment disease, 1 incidence of pulmonary embolism, 1 incidence of vascular thrombosis, 1 incidence of screw loosening, 2 incidences of hook pull-out, 1 incidence of myelopathy, 1 incidence of screw breakage, 1 incidence of hematoma, 1 incidence of screw migration, 1 incidence of csf leak, 1 incidence of thrombosis, 1 incidence of posterior rod fracture, 1 incidence of meningeal injury, 1 incidence of inadequate deformity correction.Bilateral rod fractures documented above were not depuy-synthes rods.There were two broken buried screws in l5 and s1.This report involves one unk - spine screw.This is report 5 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.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: this report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (ddra) for patients undergoing: a real-world analysis to evaluate the clinical outcomes of patients requiring anterior reconstruction of the cervical, thoracic, or lumbar spine with the synmesh cage.Analysis years were from 2017 ¿ 2020.Adverse events were as follows: 34 incidences of neurological deficit, two required revision.8 instances of infection.8 instances of loss of fixation, three required revision.8 instances of nonunion, four required revision.6 instances of cardiovascular complication.4 instances of proximal junctional kyphosis, four required revision.3 incidences of wound dehiscence.2 instances of vascular complications.2 incidences of pulmonary complications.2 incidences of adjacent compression fracture.2 incidences of adjacent segment disease.1 incidence of pulmonary embolism.1 incidence of vascular thrombosis.1 incidence of screw loosening.2 incidences of hook pull-out.1 incidence of myelopathy.1 incidence of screw breakage.1 incidence of hematoma.1 incidence of screw migration.1 incidence of csf leak.1 incidence of thrombosis.1 incidence of posterior rod fracture.1 incidence of meningeal injury.1 incidence of inadequate deformity correction, one required revision.Bilateral rod fractures documented in cer were not depuy-synthes rods.There were two broken buried screws in l5 and s1.This report involves one unk - spine screw.This is report 5 of 6 for (b)(4).
 
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Brand Name
UNK - SCREWS: SPINE-US
Type of Device
ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
Manufacturer Contact
kate karberg
1302 wrights lane east
west chester, PA 19380
8472871282
MDR Report Key17115089
MDR Text Key317038177
Report Number8030965-2023-07385
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Study,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/13/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/30/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
UNK - RODS; UNK - SCREWS: SPINE-US; UNK - SCREWS: SPINE-US; UNK - VERTEBRAL BODY REPLACEMENT - MESH: SYNMESH
Patient Outcome(s) Required Intervention;
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