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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 7.0MM TI USS POLYAXIAL SCREW 55MM THREAD LENGTH ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

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OBERDORF SYNTHES PRODUKTIONS GMBH 7.0MM TI USS POLYAXIAL SCREW 55MM THREAD LENGTH ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD Back to Search Results
Catalog Number 04.607.057
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Nerve Damage (1979); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Additional product codes: mni, mnh, kwp, kwq. (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. 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 (b)(6) reports an event 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 spondylodese 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. The complaint involves 56 devices. Due to a limit of impacted products per complaint, this complaint will be captured under 6 separate complaints as listed below: (b)(4) (10 devices), (b)(4) (10 devices), (b)(4) (10 devices), (b)(4) (10 devices), (b)(4) (10 devices) and (b)(4) (6 devices). These complaints capture the post-op event that involved the fifty-six (56) polyaxial screws that were explanted due to hypermobility and nerve root compression and switched to a pedicle screw system, while, related complaint (b)(4) captures the intra-op events that involved the broken screws during tightening of the nut. This report is for one (1) 7. 0mm ti uss polyaxial screw 55mm thread length. This is report 10 of 10 for complaint (b)(4).
 
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Brand Name7.0MM TI USS POLYAXIAL SCREW 55MM 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)
WERK MEZZOVICO (CH)
via cavazz 5
mezzovico 6805
SZ 6805
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key8728270
MDR Text Key149064839
Report Number8030965-2019-65616
Device Sequence Number1
Product Code NKB
UDI-Device Identifier07611819185814
UDI-Public(01)07611819185814
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K082572
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 05/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number04.607.057
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/29/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/05/2019
Was Device Evaluated by Manufacturer? Yes
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: 06/24/2019 Patient Sequence Number: 1
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