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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - SCREWS: SPINE-US; SCREW, FIXATION, BONE

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SYNTHES GMBH UNK - SCREWS: SPINE-US; SCREW, FIXATION, BONE Back to Search Results
Device Problem Compatibility Problem (2960)
Patient Problem Insufficient Information (4580)
Event Date 11/01/2023
Event Type  malfunction  
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: b3: event occurred on an unknown date in november of 2023.D1, d2, d3, d4, g4 ¿ 510k: this report is for an unknown screw: spine-us/unknown lot.Part and lot numbers are unknown; udi 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.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 germany reports an event as follows: it was reported that on an unknown date in (b)(6) 2023, the screws in question would not pass through during implantation.As a result the cage could not be screwed in.There was no reported adverse patient impact.No further information is available.This report is for an unk - screw: spine-us.This is report 1 of 2 for (b)(4).
 
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Brand Name
UNK - SCREWS: SPINE-US
Type of Device
SCREW, FIXATION, BONE
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 Key18371837
MDR Text Key331092242
Report Number8030965-2023-16004
Device Sequence Number1
Product Code HWC
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/29/2023
Initial Date FDA Received12/21/2023
Supplement Dates Manufacturer Received03/25/2024
Supplement Dates FDA Received03/25/2024
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
SYNFIX EVOLUTION SPACER LRG H13.5 14°.
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