MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SI POLYAXL SCREW 7 X 40MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number 179712740

Device Problem Break (1069)

Patient Problems Spinal Column Injury (2081); Not Applicable (3189)

Event Date 07/23/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Broken pedicle screw - incomplete l5/s1 fusion.Patient consequence?: no is the information being submitted for this complaint all the details that are known/available regarding this event?: yes.

Manufacturer Narrative

Product complaint # (b)(4).Visual examination at the macroscopic level found that the fracture was located between the ball and shank of the polyaxial screw.The distal end of the polyaxial screw was not returned for analysis.The fracture analysis exhibits two surface morphologies, a smooth region and a grainy/rough region with progression lines which are indicative of fatigue failure.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.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.A definitive root cause for the polyaxial screw shank fracturing cannot be positively determined.However, the fracture analysis report exhibits two surface morphologies, a smooth region and a grainy/rough region with progression lines which are indicative of 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 were found, 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.

• Brand Name: SI POLYAXL SCREW 7 X 40MM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7778416
• MDR Text Key: 116946177
• Report Number: 1526439-2018-50784
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034067896
• UDI-Public: (01)10705034067896
• Combination Product (y/n): N
• PMA/PMN Number: K160904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 179712740
• Device Catalogue Number: 179712740
• Device Lot Number: AVHDY7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/23/2018
• Initial Date FDA Received: 08/13/2018
• Supplement Dates Manufacturer Received: 08/31/2018
• Supplement Dates FDA Received: 09/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention