MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH ROD, 300 MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	179762300
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Not Applicable (3189)
Date of Event	12/06/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 or Problem Description
Complaint description: the experienced senior surgeon have his 3.Rodbreake - further info will come.
Additional Manufacturer Narrative
Product complaint # (b)(4).Device evaluated by manufactured: corrected.Visual examination of the returned device found the rod had fractured.An analysis was performed to investigate the fracture.The fracture exhibit two surface morphologies, a smooth and a grainy/rough region along with progression lines that are indicative of fatigue failure.No material or manufacturing irregularities were found.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 fracture of the rod intraoperatively could not be determined.However, fracture analysis of the rod suggests rod failed due to fatigue failure.No material or manufacturing irregularities were found.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: ROD, 300 MM
• 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: 7439354
• Report Number: 1526439-2018-50375
• Device Sequence Number: 11118257
• Product Code: NKB
• UDI-Device Identifier: 10705034077420
• UDI-Public: (01)10705034077420
• Combination Product (Y/N): N
• PMA/510(K) Number: K033901
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 179762300
• Device Catalogue Number: 179762300
• Device Lot Number: BDK2TS1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2018
• Initial Date Received by Manufacturer: 03/22/2018
• Supplement Date Received by Manufacturer: 04/25/2018
• Initial Report FDA Received Date: 04/18/2018
• Supplement Report FDA Received Date: 04/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1