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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 5.0MM TI SCHANZ SCREW WITH DUAL CORE 45MM THREAD/190MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

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OBERDORF SYNTHES PRODUKTIONS GMBH 5.0MM TI SCHANZ SCREW WITH DUAL CORE 45MM THREAD/190MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD Back to Search Results
Catalog Number 496.713S
Device Problem Break (1069)
Patient Problems Failure of Implant (1924); Impaired Healing (2378)
Event Type  Injury  
Manufacturer Narrative

Patient weight is unknown. Date of event is unknown. Additional procodes: mni, mnh, kwp, kwo. Device was not explanted. Reporter email address is unavailable. Please note, this dhr review is for sterilization procedure only: part no. : 496. 713s. Lot no. : l384524. Manufacturing location: (b)(6). Supplier: (b)(6). Release to warehouse date: 19. Apr. 2017. Expiry date: 01. Apr. 2027. No nonconformace records (ncr) were generated during production. 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. Non-sterile 496. 713 / 9090760 was manufactured in (b)(4). Release to warehouse date: 05. Aug. 2014. No ncrs were generated during production. 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. Product was not returned. 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 europe reports an event in (b)(6) as follows: it was reported that on (b)(6) 2017, a surgery for burst fracture at l4 was performed using the universal spine system (uss) fracture system. The fixed area was l3 ¿ l5. On (b)(6) 2018, the breakage of the reported screw was confirmed at l3 under the x-ray, and non-union was also observed. It is unknown when the breakage happened. Patient status is unknown. This report is for a 5. 0mm ti schanz screw with dual core 45mm thread/190mm. This is report 1 of 1 for (b)(4).

 
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Brand Name5.0MM TI SCHANZ SCREW WITH DUAL CORE 45MM THREAD/190MM
Type of DeviceORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
SYNTHES SELZACH
bohackerweg 5
selzach 2545
SZ 2545
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key7506158
MDR Text Key107970671
Report Number8030965-2018-53684
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK082572
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/20/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/11/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number496.713S
Device LOT NumberL384524
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/12/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured04/19/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 05/11/2018 Patient Sequence Number: 1
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