MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXP5.5 455MM CONTOUR COCR ROD; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	196791455
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Pc: surgical intervention.(b)(4).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
The following was reported: revision t4-pelvis & broken pedicle screws: dr (b)(6), (b)(6) hospital, (b)(6) 2019.Pt had a posterior spinal fusion for spinal deformity, t4-pelvis ((b)(6) 2016).It was quite a significant deformity.It was noted that the rods broke at l1 (2018) where there is a non-union.This is stage 1 of 2.The rods were removed on both sides, broken screws removed, new screws implanted and then new cocr rods.Two new sfx cross connectors were also used.Impacted product: unknown spd= 5.5mm rod, ti, code: 2797.62.300, not available.

• Brand Name: EXP5.5 455MM CONTOUR COCR ROD
• 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: 8400607
• Report Number: 1526439-2019-51427
• Device Sequence Number: 10867808
• Product Code: NKB
• UDI-Device Identifier: 10705034295312
• UDI-Public: (01)10705034295312
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K082942
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/20/2019

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: 196791455
• Device Catalogue Number: 196791455
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/20/2019
• Initial Report FDA Received Date: 03/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR