MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MIS CANN POLY SCW 6X45MM,TI; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	186715645
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Visual examination found that the initial threads on the tulip head are torn.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 mis cannulated poly screw 6x45mm, ti 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.
Event or Problem Description
It was reported that ,after final tightening of the single inner setscrew, the rod came out damaging the head of the poly screw and the single inner setscrew.Later 2 single inner setscrews were tried but that too got damaged.

• Brand Name: MIS CANN POLY SCW 6X45MM,TI
• 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: 8243811
• Report Number: 1526439-2019-51222
• Device Sequence Number: 2463530
• Product Code: NKB
• UDI-Device Identifier: 10705034122359
• UDI-Public: (01)10705034122359
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/04/2018

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: 186715645
• Device Catalogue Number: 186715645
• Device Lot Number: AVDCNF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2019
• Initial Report FDA Received Date: 01/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1