MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SI POLYAXL SCREW 7 X 35MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	179712735
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/02/2018
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
The l5 lumbar spondylolisthesis reconstruction surgery was performed with expedium si and hook system on (b)(6) 2018.It was reported that the surgeon could not apply the torque for final tightening the set screws.The surgeon confirmed there was no cross-threaded, so that the surgeon attempted to tighten couple of time, but the surgeon could not tighten the set screws.Then, the surgery was completed by replacing the screw which removed from the patient¿s lumbar.After the removing the screws, the surgeon recognized there was metal like fragment around the screw.There was 45min surgical delay and there was no adverse consequence to the patient.No further information was provided by the hospital.
Additional Manufacturer Narrative
(b)(4).Visual examination found that the tulip head¿s threads were torn off.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 torn threads on the si polyaxial screw 7 x 35mm cannot be determined.Noted damage suggests that inadvertently cross threading of the setscrew occurred upon insertion into the tulip head.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.
Additional Manufacturer Narrative
(b)(4).Date of awareness for follow up # (b)(4) should have been 11/20/2018 not 11/2/2018.

• Brand Name: SI POLYAXL SCREW 7 X 35MM
• 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: 8071201
• Report Number: 1526439-2018-51067
• Device Sequence Number: 19221913
• Product Code: NKB
• UDI-Device Identifier: 10705034067889
• UDI-Public: (01)10705034067889
• Combination Product (Y/N): N
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/02/2018

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: 179712735
• Device Catalogue Number: 179712735
• Device Lot Number: AHDBK1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2018
• Initial Date Received by Manufacturer: 11/02/2018
• Supplement Date Received by Manufacturer: 11/02/2018; 01/03/2019
• Initial Report FDA Received Date: 11/14/2018
• Supplement Report FDA Received Date: 12/03/2018; 01/03/2019
• 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: Other