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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 45MM THREAD LENGTH ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

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OBERDORF SYNTHES PRODUKTIONS GMBH 7.0MM TI MATRIX POLYAXIAL SCREW 45MM THREAD LENGTH ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD Back to Search Results
Catalog Number 04.632.745
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 45mm thread length. This report is 1 of 4 for (b)(4).

 
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Brand Name7.0MM TI MATRIX POLYAXIAL SCREW 45MM THREAD LENGTH
Type of DeviceORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
BRANDYWINE
1303 goshen parkway
west chester PA 19380
Manufacturer Contact
kara ditty-bovard
eimattstrasse 3
oberdorf 4436
SZ   4436
6103142063
MDR Report Key8254076
MDR Text Key133318544
Report Number8030965-2019-59943
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeCH
PMA/PMN NumberK100952
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
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 Number04.632.745
Device LOT NumberH184114
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/04/2019
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/12/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/08/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 01/16/2019 Patient Sequence Number: 1
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