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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TI PARALLEL CONNECTOR 5.0MM/6.0MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
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OBERDORF SYNTHES PRODUKTIONS GMBH TI PARALLEL CONNECTOR 5.0MM/6.0MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Catalog Number 498.162
Device Problem Mechanical Problem (1384)
Patient Problems Failure of Implant (1924); No Code Available (3191)
Event Date 01/01/2019
Event Type  Injury  
Manufacturer Narrative
Date of event: only event year is known.Additional device product codes: mni, kwq, kwp, mnh.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is a synthes employee.Part # 498.162.Synthes lot # 7538231.Supplier lot # na.Release to warehouse date: february 28, 2014.Manufactured by synthes (b)(4).No ncr's were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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.(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 (b)(6) as follows: it was reported that on an unknown date, that a patient had a thoracic spinal stenosis procedure and on (b)(6) 2019 it was discovered that the connector device did not lock, resulting in the detachment of the titanium rod.On (b)(6) 2019, a second surgery was performed to replace the connector device.On (b)(6) 2019 the patient¿s condition was reported as improved.Concomitant devices reported: rods: spine (part number unknown, lot unknown, quantity 1).This report involves one (1) ti parallel connector 5.0mm/6.0mm.This is report 1 of 2 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.
 
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.
 
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.
 
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Brand Name
TI PARALLEL CONNECTOR 5.0MM/6.0MM
Type of Device
ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key10586705
MDR Text Key208543633
Report Number8030965-2020-07441
Device Sequence Number1
Product Code NKB
UDI-Device Identifier07611819717206
UDI-Public(01)07611819717206
Combination Product (y/n)N
PMA/PMN Number
K141897
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup
Report Date 09/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/25/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number498.162
Device Lot Number7538231
Was Device Available for Evaluation? No
Date Manufacturer Received11/04/2020
Patient Sequence Number1
Treatment
PARALL-CONNEC F/USS SMALL STATURE/PAEDIA; UNK - RODS; PARALL-CONNEC F/USS SMALL STATURE/PAEDIA
Patient Outcome(s) Required Intervention;
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