MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MON ROD, 5.5MM X 600MM, TI; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

Model Number	177470600
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product code: kwp; mni.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(b)(4).Device was used for treatment, not diagnosis.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 on (b)(6) 2020, the surgeon put on a revision surgery where a broken rod was suspected in a t10-pelvis construct that was originally implanted on ''(b)(6) 201'' wherein a single 5.5x600mm rod was cut to make 2 rods.Once the construct was exposed, the rod was identified to be broken on both sides of the construct.A pseudoarthrosis was dictated as the reason for the hardware breakage.Eleven (11) expedium screws were removed (due to loosening caused by the pseudoarthrosis) and replaced with new rods and connectors.There were no patient consequences.Procedure outcome is unknown.Concomitant device reported: unknown set screws (part# unknown, lot# unknown, quantity unknown).This complaint involves twelve (12) devices.This report is for (1) mon rod, 5.5mm x 600mm, ti.This is report 1 of 10 for (b)(4).Related product complaint: (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h6: code 3191 used to capture surgical intervention and medical device removal.H11 corrected data: d11: disregard (b)(4), for unknown screws.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: MON ROD, 5.5MM X 600MM, TI
• Common Device Name: ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10261080
• Report Number: 1526439-2020-01319
• Device Sequence Number: 17081070
• Product Code: MNH
• UDI-Device Identifier: 10705034062532
• UDI-Public: (01)10705034062532
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K024348
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2020

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: 177470600
• Device Catalogue Number: 177470600
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/25/2020
• Supplement Date Received by Manufacturer: 07/13/2020
• Initial Report FDA Received Date: 07/10/2020
• Supplement Report FDA Received Date: 08/06/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN LOCKING/SET SCREWS.; UNKNOWN SCREWS.
• Outcome Attributed to Adverse Event: Required Intervention