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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SYNTHES SPINE SCREW, CORTICAL FIX, POLYAXIAL, MIS 5.5, TI, 6X50MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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DEPUY SYNTHES SPINE SCREW, CORTICAL FIX, POLYAXIAL, MIS 5.5, TI, 6X50MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Catalog Number 186731650
Device Problem Break (1069)
Patient Problems Unspecified Infection (1930); Tissue Damage (2104); Injury (2348)
Event Date 02/22/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). A follow up report will be filed upon completion of the investigation. 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 found that the cannulated cortical fix screw (both part and lot numbers unknown yet) in the patient¿s body had been broken on (b)(6) 2017. This incident might have been caused by overload to the screw due to infection. An explant is planned on (b)(6) 2017.
 
Manufacturer Narrative
Udi: (b)(4). One (1) viper 6x50mm cortical fix top loading shank polyaxial screw [product code: 1867-31-650, lot no: argbvv] was returned to the customer quality unit (cqu) for evaluation. Visual examination at the macroscopic level revealed that the polyaxial screw fractured in the neck region of the screw shank. The fracture analysis report reveals that the fracture is evident of a fatigue failure. No material defects or other abnormalities were observed in this analysis. Infection resulted in damage to vertebral body. Instability of bone surrounding the screw may have put additional stress on screw head resulting in screw breakage. A review of the device history record was conducted. No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer. No emerging trends were found requiring further actions. A definitive root cause for the polyaxial screw fracturing cannot be positively determined. However, the fracture analysis report reveals that the fracture is evident of a fatigue failure. As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends requiring immediate action have been observed, this complaint file will be closed with no further action required. 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 NameSCREW, CORTICAL FIX, POLYAXIAL, MIS 5.5, TI, 6X50MM
Type of DeviceORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
Manufacturer (Section D)
DEPUY SYNTHES SPINE
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
MEDOS INTERNATIONAL SARL
chemin blanc 38
le locle CH-24 00
SZ CH-2400
Manufacturer Contact
jason busch
325 paramount drive
raynham, MA 02767
5088808201
MDR Report Key6414398
MDR Text Key70252001
Report Number1526439-2017-10198
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110216
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 02/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/17/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number186731650
Device Lot NumberARGBVV
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/30/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/10/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/13/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 03/17/2017 Patient Sequence Number: 1
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