MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MNTR OC PREBENT ROD 3.5X120; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Model Number	188363200
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 or Problem Description
It was reported that ,the two mountaineer rods were implanted 2 years ago on female patient d.O.B (b)(6).Diagnosis : broken rods previous implanted 2 years prior from the occiput to c5 posterior fusion.The rods broke.The patient presented with diabetes as a comorbidity.The 2 rods were explanted for new rods on (b)(6) 2018.Patient exposed to additional 90 minutes of anesthesia as a result.Dr (b)(6) would like (b)(6), phd engineer to inspect the explanted rods.
Additional Manufacturer Narrative
Product complaint # (b)(4).A fracture analysis was performed to investigate the fracture of the mountaineer 3.5mm titanium rod.Optical images of the fractured surface exhibit two surface morphologies a smooth and a grainy/rough region and progression lines which are indicative of fatigue failure.The exact part and lot number combination are unknown; therefore, the manufacturing or receiving inspection records could not be reviewed.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 mountaineer rod could not be determined from the given information.However, fracture analysis report suggests that rod fractured due to 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: MNTR OC PREBENT ROD 3.5X120
• Common Device Name: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 7641242
• Report Number: 1526439-2018-50593
• Device Sequence Number: 2435248
• Product Code: NKG
• UDI-Device Identifier: 10705034159027
• UDI-Public: (01)10705034159027
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K042508
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2018

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: 188363200
• Device Catalogue Number: 188363200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2018
• Initial Date Received by Manufacturer: 06/04/2018
• Supplement Date Received by Manufacturer: 07/02/2018
• Initial Report FDA Received Date: 06/27/2018
• Supplement Report FDA Received Date: 07/11/2018
• 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
• Patient Age: 77 YR