MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER T27 ILIAC SCREW 9X100,TI; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	179706999
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
It was reported that dr.(b)(6) was revising a 9x100mm fully threaded iliac screw on (b)(6) 2018.The implant was loose which required it to be replaced.Dr.(b)(6) successfully removed a 9x100mm fully threaded sai screw (1797-06-999) on the right.He then proceeded to use a 10mm sai tap and tapped the full length of 100mm in the same screw hole where he removed the 9x100mm screw.He then placed the new 10x100mm screw.At 80mm he began to see increased resistance.He then took a t-handle and attached it to the sai screwdriver.Upon 5mm of additional insertion, the tip of the screwdriver broke (15mm of screw threads exposed).He tried to remove the screw by ¿helicoptering¿ the screw out using a custom device.He was unable to remove the screw.He decided to wait till friday, (b)(6) 2018 to remove the screw and replace it.The (b)(6) 2018 revision was already scheduled for implanting rods and new expedium inner screws.Patient consequence? :yes.Patient consequence description: additional anesthesia incurred in attempt to remove the screw (from the broken screwdriver, 15 minutes.Action taken for procedure:revision (b)(6) 2018.Surgery was already planned for putting new rods and set screws, but dr.(b)(6) will have to take time to removed the 10x100mm screw, and replace it.Concomitant device : #1797-06-099, lot # unk quantity 1.

• Brand Name: VIPER T27 ILIAC SCREW 9X100,TI
• 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: 7784211
• Report Number: 1526439-2018-50791
• Device Sequence Number: 18889110
• Product Code: NKB
• UDI-Device Identifier: 10705034266602
• UDI-Public: (01)10705034266602
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/25/2018

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: 179706999
• Device Catalogue Number: 179706999
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2018
• Initial Report FDA Received Date: 08/15/2018
• 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