MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH ROD, STR, TI, 450MM (HX END); ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	179963450
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Pc: surgical intervention in the form of revision surgery.(b)(4)-unknown.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
It was reported that the primary surgery was performed on unknown date to fix thoracic spine (position was unknown) to s2 with expedium 6.35 system via posterior spine fusion, however, both rod ends were not connected.On (b)(6) 2018, the reinforcement surgery was planned to revise the rod where implanted to superior head side, and the connect with new rod to reinforce the connection.At that time, the sales rep heard the system name which had been implanted was just ¿expedium¿ from the doctor, so he thus, the sales force prepared all kinds implants of connector i.E.Side-side, end-end, universal, lateral, transverse (p/n and lot number were unknown), new rods (p/n and lot number were unknown), and di screw (9mm and 10mm, p/n and lot number were unknown) of expedium 5.5 system.Then, on (b)(6) 2018, the reinforcement surgery was performed.During the surgery, the surgeon recognized that the inferior tail side screw was loosened when removed the set screw and rod, so that the surgeon tried to remove the screw underneath by using insitu rod bender.However, the rod bender was not fit the rod, and then, it was just noticed the surgeon recognized the all implants were expedium 6.35 system which is not compatible to prepared expedium 5.5 system.Thus, the surgery was aborted, and the surgeon closed operation field in consideration of the patient¿s physical strength.No further information was provided by the hospital.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: ROD, STR, TI, 450MM (HX END)
• 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: 8156490
• Report Number: 1526439-2018-51135
• Device Sequence Number: 1732094
• Product Code: NKB
• UDI-Device Identifier: 10705034091679
• UDI-Public: (01)10705034091679
• Combination Product (Y/N): N
• PMA/510(K) Number: K062174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2018

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: 179963450
• Device Catalogue Number: 179963450
• Device Lot Number: BDH75TR
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/18/2018
• Supplement Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 12/12/2018
• Supplement Report FDA Received Date: 12/17/2018
• 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