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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - SCREWS: ZERO-P THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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SYNTHES GMBH UNK - SCREWS: ZERO-P THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Device Problems Mechanical Problem (1384); Material Integrity Problem (2978)
Patient Problem Failure of Implant (1924)
Event Type  Injury  
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. 510k: this report is for an unknown device/unknown lot. Part and lot numbers are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. Without a lot number the device history records review could not be completed. 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
This report is being filed after the review of the following journal article: chen guangmei (2020), perioperative nursing care of patients with cervical disc herniation undergoing anterior decompression and internal fixation with steel plate (china). The objective of this study is to explore the perioperative nursing methods and effects of anterior decompression and plate internal fixation in the treatment of cervical disc herniation. From may 2018 to december 2019, 85 patients with cervical disc herniation underwent anterior decompression and plate internal decompression. The patients were divided into 2 groups; observation group (n
=
42) and the control group (n
=
43). The observation group consisted of 23 males and 19 females with the age range from 35-67 years. Th e control group consisted of 22 males and 21 females with an age range from 33-65 years. All patients were treated with anterior decompression plate (johnson & johnson, zero p. The following complications were reported as follows: (n
=
5) screw loosening, (n
=
1) broken screw. This report is for unk - screws: zero-p. This is report 1 of 1 for (b)(4).
 
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Brand NameUNK - SCREWS: ZERO-P
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key15182793
MDR Text Key297425981
Report Number8030965-2022-05626
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/08/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/12/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 08/08/2022 Patient Sequence Number: 1
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