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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH USS-II SLEEVE TOOTHED F/R 6 TAN VIOL; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
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OBERDORF SYNTHES PRODUKTIONS GMBH USS-II SLEEVE TOOTHED F/R 6 TAN VIOL; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD Back to Search Results
Catalog Number 499.302
Device Problem Material Integrity Problem (2978)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Device is not distributed in the united states, but is similar to device marketed in the usa.The investigation could not be completed; no conclusion could be drawn, as no product was received.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, the sleeve on the left hook t3 failed.This occurred after successfully placing all the implants, placing the two rods, and all the corresponding sleeves and nuts.The surgeon started final tightening of all the nuts when the sleeve on the left hook t3 failed.No further information provided.Concomitant device reported: unknown uss ii rod (part # unknown, lot # unknown, quantity unknown).Unknown uss ii nut (part # unknown, lot # unknown, quantity unknown).This report is for one (1) ti collar for 6.0mm rods for uss dual-opening.This is report 1 of 1 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.The complaint condition that the device is cracked, could be confirmed according to the received pictures.Product was not returned.Based on the information available, it has been determined that no corrective and 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 history part: 499.302s, lot: 6l49339, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: 05.Dec.2019, expiry date: 01.Dec.2029.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Non-sterile part: 499.302, lot: 6l06717, manufacturing site: mezzovico, release to warehouse date: 09.Sep.2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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
Update: the broken sleeve was identified during surgery while the final tightening was happening and was removed immediately a replacement sleeve was used to complete the surgery.Patient status was listed as "fine" stable post operatively.This complaint is linked to (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.
 
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Brand Name
USS-II SLEEVE TOOTHED F/R 6 TAN VIOL
Type of Device
ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key9847838
MDR Text Key191682333
Report Number8030965-2020-02045
Device Sequence Number1
Product Code NKB
UDI-Device Identifier07611819967311
UDI-Public(01)07611819967311
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 02/18/2020
1 Device was Involved in the Event
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
Device Catalogue Number499.302
Device Lot Number6L49339
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/18/2020
Initial Date FDA Received03/18/2020
Supplement Dates Manufacturer Received03/27/2020
04/22/2020
Supplement Dates FDA Received04/21/2020
04/23/2020
Patient Sequence Number1
Treatment
UNK - RODS: USS; UNK - RODS: USS; UNK - SCREW/ROD CONSTRUCT ACCESSORIES: USS; UNK - SCREW/ROD CONSTRUCT ACCESSORIES: USS; USS-II SLEEVE TOOTHED F/R Ø6 TAN VIOL
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