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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SPINE INC 5.5 EXP VERSE SCREW 7.0 X 40 ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

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DEPUY SPINE INC 5.5 EXP VERSE SCREW 7.0 X 40 ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD Back to Search Results
Model Number 199721740
Device Problems Break (1069); Crack (1135)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/24/2020
Event Type  malfunction  
Manufacturer Narrative
Additional narrative: additional procode: kwp, kwq, mnh, mni, osh. The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report. 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
It was reported that on (b)(6) 2020, the threads on an 7. 0x40mm expedium verse screw at left l5 came dislodged and prevented the verse correction key from threading down entirely making it impossible to final tighten the setscrew. The screw was removed and replaced with another 7. 0x40mm expedium verse screw. The procedure was successfully completed with a surgical delay of ten (10) minutes. The patient status/outcome is unknown. Concomitant device reported: unknown tightener (part# unknown, lot# unknown, quantity unknown ). Unknown locking/set screws (part# unknown, lot# unknown, quantity unknown ). This report is for one (1) 5. 5 exp verse screw 7. 0 x 40. This is report 1 of 1 for (b)(4).
 
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Brand Name5.5 EXP VERSE SCREW 7.0 X 40
Type of DeviceORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
Manufacturer (Section D)
DEPUY SPINE INC
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
BRIDGEWATER DISTRIBUTION
50 scotland boulevard
bridgewater MA 02324
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key10421091
MDR Text Key203533117
Report Number1526439-2020-01489
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10705034442112
UDI-Public(01)10705034442112
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142185
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/24/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number199721740
Device Catalogue Number199721740
Device Lot Number258745
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/07/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/21/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/21/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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