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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); Patient Device Interaction Problem (4001)
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. This report is for an unknown screws: zero-p/unknown lot. Part and lot number are unknown. Without the specific part number; the udi number and 510-k 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
Device report from synthes reports an event in india as follows: this report is being filed after the review of the following journal article: meena, r. K. Et al. (2022), trans-oesophageal migration of pulled-out locking screw (zero-profile implant system) and its retrieval using suction catheter: a technical note, neurology india, vol 70(2), pages 749-752 (india). This study presents a case report of a (b)(6) female patient who presented with spastic quadriparesis. She underwent c5-c6 anterior cervical discectomy and fusion (acdf). Nine months following the surgery, x-ray cervical spine showed implant loosening and failure of fusion across the instrumented disc space. However, during revision surgery, the loosened screw could not be located visually in the initial attempts, though it could be felt by probing the prevertebral space with the index finger. Intraoperative x-rays showed that the screw migrated curiously in the cranial direction as the surgical field was probed further manually. The screw was then finally retrieved using magill's forceps assisted by video laryngoscopy assisted by intermittent negative pressure application via a blunt-tipped suction catheter. Result(s): she was discharged home on a philadelphia collar, and at 1 year of follow-up, she was completely asymptomatic. This report is for an unknown synthes zero-p. This is report 2 of 2 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 Key15129128
MDR Text Key296859892
Report Number8030965-2022-05394
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeIN
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 Received07/29/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/30/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes

Patient Treatment Data
Date Received: 07/29/2022 Patient Sequence Number: 1
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