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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SPINE INC VIPER PRIME X-TAB POLYAXIAL SCREW 5.5 7 X 40MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
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DEPUY SPINE INC VIPER PRIME X-TAB POLYAXIAL SCREW 5.5 7 X 40MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD Back to Search Results
Catalog Number 186770240
Device Problem Migration (4003)
Patient Problem Insufficient Information (4580)
Event Date 01/01/2023
Event Type  Injury  
Event Description
It was reported that on an unknown date in 2023, the subsidence into l4 with xpac l4 pedicle screws failed.The patient experienced subsidence of l4 interbody.Because of the failure, two new unknown pedicle screws were added.No further information is available.This report is for an unk - screw: pedicle.This is report 2 of 2 for (b)(4).
 
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.H10 additional narrative: b3: event occurred on an unknown date in 2023.D1, d2, d3, d4, g4 ¿ 510k: this report is for an unknown screw: pedicle/unknown lot.Part and lot numbers are unknown; udi number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: 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 involves one viper prime x-tab polyaxial screw 5.5 7 x 40mm.This is report 2 of 6 for (b)(4).
 
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.A1, a2, a3: patient information added.B5: event description updated.D2b: additional device product codes: kwp, osh, kwq, mni, mnh.D4: catalog number, udi added.D6a, d6b: implant and explant dates added.G4: 510k added.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.D1: brand name updated.D2a, d2b: procode updated.D10: concomitant devices updated.H6: health effect impact code updated.
 
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.H6: a photo investigation was conducted.The product was not returned to depuy synthes, however photos were provided for review.Visual analysis of the provided series of radiographs revealed that there was found the viper prime x-tab, 7x40mm ti located in the l5 with no damage.The allegation of migration cannot be confirmed.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was unconfirmed as the observed condition of the viper prime x-tab, 7x40mm ti would not contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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.
 
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Brand Name
VIPER PRIME X-TAB POLYAXIAL SCREW 5.5 7 X 40MM
Type of Device
ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
Manufacturer (Section D)
DEPUY SPINE INC
325 paramount drive
raynham MA 02767
Manufacturer Contact
kate karberg
325 paramount drive
raynham, MA 02767
3035526892
MDR Report Key18072401
MDR Text Key327358210
Report Number1526439-2023-02207
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10705034509464
UDI-Public(01)10705034509464
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162912
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received11/06/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number186770240
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/24/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
UNK - SCREWS: PEDICLE.; VIPER PRIME X-TAB, 6X40MM TI.; VIPER PRIME X-TAB, 6X40MM TI.; VIPER PRIME X-TAB, 6X40MM TI.; VIPER PRIME X-TAB, 6X40MM TI.; VIPER PRIME X-TAB, 7X40MM TI.; X-PAC 10X25MM LORDOTIC.; X-PAC 10X25MM LORDOTIC.
Patient Outcome(s) Required Intervention;
Patient Age60 YR
Patient SexFemale
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