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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SPINE INC 5.5 EXP VERSE CAN SCR 5.0X45 ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

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DEPUY SPINE INC 5.5 EXP VERSE CAN SCR 5.0X45 ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD Back to Search Results
Catalog Number 199725545S
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem Foreign Body In Patient (2687)
Event Type  Injury  
Manufacturer Narrative

Additional procode: kwp;kwq;mnh;mni;osh. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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 (b)(6) as follows: it was reported that on an unknown date, the patient underwent removal surgery to remove the implants after the primary fusion procedure treating burst fracture. It was found that the 5. 5 exp verse screw at i3 had broken off in the patient. The screw remains in the patient's body. There is no further information available. This report is for one (1) 5. 5 exp verse can scr 5. 0x45. This is report 1 of 1 for (b)(4).

 
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Brand Name5.5 EXP VERSE CAN SCR 5.0X45
Type of DeviceORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
Manufacturer (Section D)
DEPUY SPINE INC
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
chemin-blanc 38
le locle 02400
SZ   02400
6103142063
MDR Report Key12370149
MDR Text Key268222483
Report Number1526439-2021-01761
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK142185
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/30/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/26/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number199725545S
Device LOT Number257069
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/01/2021
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/16/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/25/2019
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: 08/26/2021 Patient Sequence Number: 1
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