MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE SCREW 7.0 X 45; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	199721745
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Pc: surgical intervention, medical device removal.(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 on (b)(6) 2019, patient underwent revision surgery or the rod reduction, there was a pull-out of two (2) screws with 7mm diameter which were removed and replaced with two (2) 8mm screws.During the insertion of one of the 8mm screws, a pedicle fracture happened.The construct consists now of five (5) screws (2 screws in s1, 1 screw in l5 and 2 screws in l4) connected with the sfx connector.The surgeons managed to correct the spondylolisthesis from stage 2 to stage 1 with an anterior osteophyte on l4 that could not be removed during the surgery.There was a surgical delay of 20 minutes.The patient and procedure outcome were unknown.This complaint involves six (6) devices.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: 5.5 EXP VERSE SCREW 7.0 X 45
• 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: 8812819
• Report Number: 1526439-2019-51852
• Device Sequence Number: 2470792
• Product Code: NKB
• UDI-Device Identifier: 10705034442105
• UDI-Public: (01)10705034442105
• Combination Product (Y/N): N
• Initial Reporter Country: ES
• PMA/510(K) Number: K142185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2019

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: 199721745
• Device Catalogue Number: 199721745
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/27/2019
• Supplement Date Received by Manufacturer: 07/25/2019
• Initial Report FDA Received Date: 07/22/2019
• Supplement Report FDA Received Date: 08/09/2019
• 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