MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXP TI UNI SCREW 6MM X 45MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	179788640
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Codes	Spinal Column Injury (2081); Not Applicable (3189)
Date of Event	04/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
Scoliosis fusion was performed 2016.Set screw seemed to slip on post opt month 3.Continued to slip until the rod slipped into the tulip head of the screw.Pseudo occurred.Revised on (b)(6) 2018 and found that set screws were loose and most distal screw head was popped off.Patient consequence? yes.Patient consequence description: revision surgery.Action taken for procedure:there was no major issue.Rod was cut.Three screws were removed.Three screws were replaced with larger diameter screws, and an inline rod connector was placed.Bone graft was placed and patient was closed.Is the information being submitted for this complaint all the details that are known/available regarding this event? yes.
Additional Manufacturer Narrative
Product complaint # (b)(4).Visual examination of the screw revealed that the screw head was disassembled from the shank, with broken saddle intact in the screw head.Exerting a significant amount of force on the tulip head and saddle, potentially at a significant angle, may be sufficient to dislodge the saddle and other parts of the screw from one another, forcing the shank through the bottom of the tulip head as a result.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.With the information provided, a definitive root cause for the loosening and falling apart of the screw cannot be determined.In general, patient factors that may affect the performance of the components include patient anatomy, bone quality, activity level, type of activity (low impact vs.High impact), and relevant medical history.Rehabilitation protocol and adherence thereto are unknown.A potential root cause for screw falling apart may be excessive force placed on the screw in-vivo, potentially at a significant angle, resulting in the screw disassembling.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: EXP TI UNI SCREW 6MM X 45MM
• 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: 7475359
• Report Number: 1526439-2018-50437
• Device Sequence Number: 13944023
• Product Code: NKB
• UDI-Device Identifier: 10705034081397
• UDI-Public: (01)10705034081397
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2018

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: 179788640
• Device Catalogue Number: 179788645
• Device Lot Number: TBLFR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2018
• Initial Date Received by Manufacturer: 04/10/2018
• Supplement Date Received by Manufacturer: 05/30/2018
• Initial Report FDA Received Date: 05/01/2018
• Supplement Report FDA Received Date: 05/31/2018
• 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