MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MIS SINGLE INNER SETSCW; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number 186715000

Device Problem Material Split, Cut or Torn (4008)

Patient Problems No Consequences Or Impact To Patient (2199); Not Applicable (3189)

Event Date 09/18/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).(b)(4), (11)unknown, (10)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 Description

Mr (b)(6) was performing a second stage fixation using viper2 following an l4/5 olif.During final tightening the nut on the right l5 screw seemed to slip when trying to final tighten.I suggested to the surgeons they remove the nut to inspect.On doing so it was clear the nut was cross threaded with some of the threads having sheared off the nut.It was highlighted that the sheared nut may be contained in the screw head, however the surgeon couldn¿t visualize as the operation was mis.He requested a new nut in any case, inserted and successfully final tightened.Concomitant device reported: unknown screwdriver (part#unknown, lot#unknown, quantity 1).This complaint involves one (1) device.

Manufacturer Narrative

(b)(4).Additional information: concomitant products.

Manufacturer Narrative

Product complaint # (b)(4).

• Brand Name: MIS SINGLE INNER SETSCW
• Type of Device: 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: 9210689
• MDR Text Key: 163191891
• Report Number: 1526439-2019-52229
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034121192
• UDI-Public: (01)10705034121192
• Combination Product (y/n): N
• PMA/PMN Number: K160904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 186715000
• Device Catalogue Number: 186715000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN SCREWDRIVERS; UNKNOWN SCREWS
• Patient Outcome(s): Other