MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE SCREW 6.0 X 50; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	199721650
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Unspecified Infection (1930); Not Applicable (3189)
Date of Event	02/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation 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
Patient was scheduled to have a hardware removal due to infection.Previous construct was t3-l3, depuy synthes spine verse product was used.L3 level of the construct, shaft of the screw was broke on the right side, l3 left pedicle screw, tulip was completely separated from the shaft of the screw.All of the unitized set screws product code 199721001 we loose and almost disengaging from the tulip.All of the unitized set screws were very loose.Patient consequence?: yes.Patient consequence description:patient had revision of previous spinal fusion where all of the hardware was removed.Is the information being submitted for this complaint all the details that are known/available regarding this event?: yes.See related incident (b)(4) for remaining products.
Additional Manufacturer Narrative
Product complaint # (b)(4).The returned polyaxial screw¿s tulip head and saddle had completely separated from the screw shank.The tulip head, saddle, and screw head all remain in good condition.However, two shiny grooves were found around the lip of the base of the tulip head a review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.The root cause of the flex ball breaking and the tulip head, saddle, and screw head separating cannot be determined from the samples and the information provided.A potential root cause may be excessive force placed on the polyaxial screw during tightening.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends were found, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 5.5 EXP VERSE SCREW 6.0 X 50
• 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: 7337681
• Report Number: 1526439-2018-50220
• Device Sequence Number: 16600845
• Product Code: NKB
• UDI-Device Identifier: 10705034442266
• UDI-Public: (01)10705034442266
• Combination Product (Y/N): N
• PMA/510(K) Number: K142185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2018

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: 199721650
• Device Catalogue Number: 199721650
• Device Lot Number: ATMCPD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2018
• Initial Date Received by Manufacturer: 02/20/2018
• Supplement Date Received by Manufacturer: 04/25/2018
• Initial Report FDA Received Date: 03/14/2018
• Supplement Report FDA Received Date: 04/27/2018
• 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