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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 7.0MM TI MATRIX POLYAXIAL SCREW 40MM THREAD LENGTH; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
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OBERDORF SYNTHES PRODUKTIONS GMBH 7.0MM TI MATRIX POLYAXIAL SCREW 40MM THREAD LENGTH; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD Back to Search Results
Catalog Number 04.632.740
Device Problem Naturally Worn (2988)
Patient Problem No Code Available (3191)
Event Date 12/23/2018
Event Type  Injury  
Manufacturer Narrative
Additional product codes; mnh, mni, kwq, kwp.(b)(4).The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.A review of the device history records has been requested.The investigation could not be completed; no conclusion could be drawn.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) 2018, during an unknown procedure, the threads of the four (4) pedicle matrix screws, and (1) locking cap were peeled or torn, one (1) unknown rod was damaged, and it could not be removed after locking.The surgeon had to remove the devices with an external force.The surgeon changed another same device to complete the procedure.The procedure time prolonged to 3 hours.Patient outcome is unknown.Concomitant device reported: unknown rod (part #: unknown, lot #: unknown, quantity: 1).This complaint involves four (4) devices.This report is for (1) 7.0mm ti matrix polyaxial screw 40mm thread length.This report is 4 of 4 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 history lot: brandywine dhr review, part no.: 04.632.740, lot no.: h394331, manufacturing location: brandywine, release to warehouse date: 21-jun-2017, visual inspection: visual inspection of the device shows damage to the star-drive recess and threads.The locking cap could not be separated from the rod and screw most likely due to stripped nature of the cap.The balance of the device is in worn condition.The received condition does agree with complaint description and is confirmed.A device history review, was performed for the returned instrument¿s lot number, and no ncrs, no mrrs or complaint-related issues were identified with the lot number which may have contributed to the complaint condition.Investigation conclusion: no definitive root cause was able to be determined as the circumstances surrounding the complaint are unknown.During this investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition.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.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.
 
Event Description
Device report from synthes reports an event in china as follows: it was reported that on (b)(6) 2018, during an unknown procedure, the threads of the two (2) pedicle matrix screws, and three (3) locking caps were peeled or torn, one (1) unknown rod was damaged, and it could not be removed after locking.The surgeon had to remove the devices with an external force.The surgeon used another same device to complete the procedure.The procedure time prolonged to 3 hours.Patient outcome is unknown.This report captures the intra-operative event during initial surgery while related complaint (b)(4) captures the post-operative event of pain.This is report 4 of 6 for complaint (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Corrected event description initially reported concomitant device is no longer considered as concomitant device and is now determined as reportable device.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
7.0MM TI MATRIX POLYAXIAL SCREW 40MM THREAD LENGTH
Type of Device
ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key8254087
MDR Text Key133258190
Report Number8030965-2019-59960
Device Sequence Number1
Product Code NKB
UDI-Device Identifier07611819347830
UDI-Public(01)07611819347830
Combination Product (y/n)N
PMA/PMN Number
K100952
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 12/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number04.632.740
Device Lot NumberH394331
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/04/2019
Date Manufacturer Received02/12/2019
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age60 YR
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