MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH ROD, 120MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	179762120
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Pc: surgical intervention in the form of revision surgery.(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: patient with a history of posterior arthrodesis of column l4, s1 in 2009; instrumentation review, may 2018; instrumentation revision by bar break, october 25, 2018 (s1 screw change and titanium bar change per cobalt chrome bar).(b)(6); size: 1.53 cm; background: hypertension.Product involved: 179702000 batch 185456 nails set s1; 179712640 batch 179935 poliaxial nail si 6x40; 179712735 batch ajnb97 poliaxial nail si 7x35; 179762120 batch vdl4w5r stick 120.
Additional Manufacturer Narrative
(b)(4).Device was not returned for evaluation.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.Without the return of the device, we are unable to confirm the reported issue or identify the root cause.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.Should more information and/or the sample be provided at a later time, this complaint will be reopened and device evaluated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).The device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).The rod was found to be broken at its lengthwise in three pieces.A fracture analysis was conducted on the returned device.The fracture analysis reveals 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.A definitive root cause of the rod breaking postoperatively could not be positively determined.However, the optical image of the fracture surface reveals 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, 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, 120MM
• 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: 8061051
• Report Number: 1526439-2018-51059
• Device Sequence Number: 11268799
• Product Code: NKB
• UDI-Device Identifier: 10705034077406
• UDI-Public: (01)10705034077406
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K033901
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/30/2018

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: 179762120
• Device Catalogue Number: 179762120
• Device Lot Number: BDLV6SY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2019
• Initial Date Received by Manufacturer: 10/30/2018
• Supplement Date Received by Manufacturer: 12/10/2018; 06/25/2019; 08/26/2019
• Initial Report FDA Received Date: 11/12/2018
• Supplement Report FDA Received Date: 12/10/2018; 07/18/2019; 08/27/2019
• 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: 50 YR
• Patient Weight: 61