MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE SCREW 6.0 X 45; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	199721645
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/22/2019
Type of Reportable Event	Malfunction
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
L5-s1 posterior stabilization: (b)(6) hospital, (b)(6) 2019.Patient came in to get posterior stabilization (dos (b)(6) 2019) after having an alif in 2015.Patient had a small spondi (slippage of l5 over s1).The slippage broke the two lower screws rather than pulled them out.It is thought the patient fused with slippage.Surgeon attempted to correct spondy (alignment) with verse technology, but given short rod, screw appeared to be bent at weakest/thinnest point (between threads and tulip head).Surgeon removed screw and upsized, locked down and closed.Patient outcome:no deviation from initial plan other than the exchange of one screw for another.Action taken:replacing one screw for another (larger diameter) screw.Patient age:(b)(6).Dob:(b)(6).This complaint involves one (1) device.
Additional Manufacturer Narrative
Product complaint #: (b)(4).

• Brand Name: 5.5 EXP VERSE SCREW 6.0 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: 8887588
• Report Number: 1526439-2019-51962
• Device Sequence Number: 311101
• Product Code: NKB
• UDI-Device Identifier: 10705034442273
• UDI-Public: (01)10705034442273
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K142185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 199721645
• Device Catalogue Number: 199721645
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/22/2019
• Supplement Date Received by Manufacturer: 08/19/2019
• Initial Report FDA Received Date: 08/13/2019
• Supplement Report FDA Received Date: 09/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 34 YR