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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TI COLLAR FOR 6.0MM RODS FOR USS POLYAXIAL; ORTHOSIS,PEDICLE SPINAL FIXATION
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OBERDORF SYNTHES PRODUKTIONS GMBH TI COLLAR FOR 6.0MM RODS FOR USS POLYAXIAL; ORTHOSIS,PEDICLE SPINAL FIXATION Back to Search Results
Catalog Number 04.607.412
Device Problem No Apparent Adverse Event (3189)
Patient Problems Nerve Damage (1979); Limited Mobility Of The Implanted Joint (2671)
Event Type  Injury  
Manufacturer Narrative
Additional product codes: nkb, mnh, kwp, kwq.Device evaluated by mfr: 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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, the patient underwent a spinal fusion procedure, an adjustment on level 2 due to hypermobility and nerve root compression.The patient had previous operations on levels 3, 4 & 5 with uss polyaxial cement augmentation spondylodeses on an unknown date.So all the screws were explanted and completed the surgery by switching into a pedicle screw system.There was a 120 minutes surgical delay.It was unknown if there were fragments generated from the broken devices.It was unknown if there were adverse event to the patient reported.This report is for one (1) ti collar for 6.0mm rods for uss polyaxial.This is report 5 of 10 for (b)(4).This complaint and complaints (b)(4) capture the post-operative event that involved the fifty-five (56) polyaxial screws explanted due to hypermobility and nerve root compression and switched to a pedicle screw system, while (b)(4) captures the intra-operative events that involved the broken screws during tightening of the nut.
 
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.D10, h3, h6: the device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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.The visual inspection found no product issues that could have contributed to the clinical finding this complaint was entered to capture the revision surgery due to hypermobility and nerve root compression.No product issues that could have contributed to this clinical finding were found.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Part: 04.607.412, lot: 3l21597, manufacturing site: mezzovico, release to warehouse date: 18.Feb.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.
 
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Brand Name
TI COLLAR FOR 6.0MM RODS FOR USS POLYAXIAL
Type of Device
ORTHOSIS,PEDICLE SPINAL FIXATION
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key8731707
MDR Text Key149102927
Report Number8030965-2019-65671
Device Sequence Number1
Product Code MNI
UDI-Device Identifier07611819186392
UDI-Public(01)07611819186392
Combination Product (y/n)N
PMA/PMN Number
K082572
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 05/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number04.607.412
Device Lot Number3L21597
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/29/2019
Date Manufacturer Received07/05/2019
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age66 YR
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