MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER TI SAI POLY 9X70MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	179704970
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Pc: surgical intervention in the form of revision surgery.(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
It was reported that on (b)(6) 2018, a spinal fusion surgery (primary surgery) for scoliosis was performed with cannulated sai polyaxial screw in question.The screw was inserted in s2 spine in accordance with surgical technique in the primary surgery.On (b)(6) 2018, the secondary procedure was performed.During the procedure, the surgeon found that the screw fell out from the rod.The surgeon replaced the screw with another polyaxial screw (10 mm in diameter) in the surgery.There was no surgical delay and no adverse consequence to the patient.No further information was provided by the hospital.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).
Additional Manufacturer Narrative
Product complaint # = > (b)(4).Visual examination of the screw revealed signs of operative use as evidence by superficial markings, with threads and drive feature slightly worn.Rod striations were observed on the saddle suggesting that it did have a tight fit.No other abnormalities were observed in this analysis.The investigation could not verify or identify any evidence of the instrument contribution to the reported problem.It is not suspected that the instrument failed to meet its specifications.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 analysis for the viper ti sai polyaxial 9x70mm is not necessary.The reported condition could not be confirmed as no defect or damages was found on the device during the evaluation.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: VIPER TI SAI POLY 9X70MM
• 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: 8258406
• Report Number: 1526439-2019-51242
• Device Sequence Number: 11220991
• Product Code: NKB
• UDI-Device Identifier: 10705034265827
• UDI-Public: (01)10705034265827
• Combination Product (Y/N): N
• PMA/510(K) Number: K111571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/26/2018

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: 179704970
• Device Catalogue Number: 179704970
• Device Lot Number: TBKXS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2019
• Initial Date Received by Manufacturer: 12/26/2018
• Supplement Date Received by Manufacturer: 02/26/2019; 03/19/2019
• Initial Report FDA Received Date: 01/17/2019
• Supplement Report FDA Received Date: 03/14/2019; 03/20/2019
• 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: Required Intervention