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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH MATRIX LOCKING CAP WITHOUT SADDLE; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
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OBERDORF SYNTHES PRODUKTIONS GMBH MATRIX LOCKING CAP WITHOUT SADDLE; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD Back to Search Results
Catalog Number 09.632.099
Device Problem Unintended Movement (3026)
Patient Problem No Code Available (3191)
Event Date 01/01/2020
Event Type  Injury  
Manufacturer Narrative
Event date can not recognized.Additional product code mnh, mni, kwq, kwp.Occupation: synthes employee.Pma: device is not distributed in the united states but is similar to device marketed in the usa.(b)(4).The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing 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
Device report from synthes reports an event in (b)(6) as follows: it was reported on an unknown date that the patient was underwent for a surgery to treat lumber spinal canal stenosis in l4-5 on (b)(6) 2020.A posterior lumber interbody fusion (plif) was performed to treat the parkinson patient.On (b)(6) it was found that the rod (04.636.045s) had come off and on (b)(6) the patient underwent a revision procedure.The surgeon was founded: the rod in l5 right had come off.The height between the setscrew (09.632.099s) and the screwhead (04.632.001s) fixated in l5 right was level.When the setscrew was removed smoothly, no squeaking noise was generated.It did not appear that both devices had cross-threaded.There was no issue on a rod deployed in l4 right.Concomitant device reported: locking cap (part # 09.632.099s, lot # 11l4955, quantity # 1), screw head polyaxial (part # 04.632.001s, lot # h644366, quantity # 1).This is report 01 of 03 of (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.Event occurred on an unknown date in (b)(6) 2020, device is distributed in the usa and 510k information of k120838 is correct.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.Investigation flow: device interaction/functional visual inspection: the implant was received at cq and the device appears to be in good shape, there is no evidence of damage that impacts functionality.There is no obvious visible damage that would suggest the device is inoperable.Functional test: a functional test was performed at us cq using the returned pedicle screw, rod and the locking cap.No issues were noted, the screw did not become loose and the rod stayed in place.The complaint was not able to be replicated.Therefore, the complaint is not confirmed.Dimensional inspection: based on the review of drawings, no design issues contributing to relevant complaint condition were identified.Conclusion: there is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the device did not seat properly.No new malfunctions were observed during the course of this investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed device history lot jan 24, 2020 reviewed a dhr review was not performed for this pi.This lot was manufactured by brandywine.Please reassign this task to the correct group.Feb 03, 2020: dhr review of non-sterile part number 09.632.099, lot 11l4955 was performed.Brandywine only manufactures the non-sterile part number 09.632.099 only and does not manufacture sterile part number 09.632.099s.Part number: 09.632.099, lot number: 11l4955, supplier lot number: n/a, manufacture date or release to warehouse date: 07/03/2019, expiration date: n/a, supplier/manufacture site: brandywine.No ncrs were generated during assemble production of lot number 11l4955.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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
MATRIX LOCKING CAP WITHOUT SADDLE
Type of Device
ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key9676378
MDR Text Key190562165
Report Number8030965-2020-00885
Device Sequence Number1
Product Code NKB
UDI-Device Identifier07611819607934
UDI-Public(01)07611819607934
Combination Product (y/n)N
PMA/PMN Number
K120838
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 01/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number09.632.099
Device Lot Number11L4955
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/27/2020
Date Manufacturer Received03/16/2020
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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