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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SPINE INC VIPER PRIME CFXFEN XTAB 6X50MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

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DEPUY SPINE INC VIPER PRIME CFXFEN XTAB 6X50MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD Back to Search Results
Model Number 186760450S
Device Problem Device Slipped (1584)
Patient Problems Fatigue (1849); Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. 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 united kingdom reports an event as follows: it was reported that on (b)(6) 2021 that the patient underwent a revision of the transforaminal lumbar interbody fusion (tlif) of the l4-s1 to remove lose l4 screws and the cage posteriorly. The cage was occupying the foramen. The patient was experiencing moderate back pain and leg muscle weakness following the primary procedure. The l4 screws were replaced and the cage was removed/replaced. Concomitant device: viper prime cfxfn xtb 7x55mm s (part# 186770455s, lot# unknown, qty 2). This report is for one (1) viper prime cfx fen x-tab polyaxial screw 5. 5 6 x 50mm. This is report 1 of 2 for (b)(4).
 
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Brand NameVIPER PRIME CFXFEN XTAB 6X50MM
Type of DeviceORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
Manufacturer (Section D)
DEPUY SPINE INC
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
SENTIO (INNOVATIVE SURGICAL SOLUTIONS, LLC)
50461 west pontiac trail
wixom MI 48393
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key12093880
MDR Text Key259198782
Report Number1526439-2021-01345
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K170543
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number186760450S
Device Catalogue Number186760450
Device Lot NumberTBWBJ
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/13/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/13/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/09/2018
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: 06/30/2021 Patient Sequence Number: 1
Treatment
CONCORDE PROTI, 5DG,9X12X27 MM; VIPER PRIME CFXFN XTB 6X50MM S; VIPER PRIME CFXFN XTB 7X55MM S
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