MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SI POLYAXL SCREW 7 X 60MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	179712760
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Code Available (3191)
Date of Event	10/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # = > (b)(4).Surgical intervention in the form of a revision surgery.A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that the screw was implanted in the ilium in the surgery on (b)(6) 2016.The hospital noticed that the screw had been broken in the patient¿s body before the removal surgery on (b)(6) 2018, which was performed because of infection.While the screw head was removed, the broken shaft was left in the body as planned preoperatively.There was no surgical delay.It is possible that the shaft come out from the ilium in the future.The patient is female who has parkinson¿s disease.
Additional Manufacturer Narrative
(b)(4).Visual examination at the macroscopic level found that the polyaxial screw shank had fractured.The other half of the broken screw shank was not returned for evaluation.A fracture analysis was performed.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 60MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8000194
• Report Number: 1526439-2018-51009
• Device Sequence Number: 1531295
• Product Code: NKB
• UDI-Device Identifier: 10705034067933
• UDI-Public: (01)10705034067933
• Combination Product (Y/N): N
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2018

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
• Operator of Device: Health Professional
• Device Model Number: 179712760
• Device Catalogue Number: 179712760
• Device Lot Number: APGBPZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2018
• Initial Date Received by Manufacturer: 10/10/2018
• Supplement Date Received by Manufacturer: 11/02/2018
• Initial Report FDA Received Date: 10/24/2018
• Supplement Report FDA Received Date: 11/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention