MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH ADJUST WEDDING BAND 3.5-5.5; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Model Number	188311302
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	08/06/2018
Type of Reportable Event	Malfunction
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
It was reported mountaineer part # 1883-11-302- adjustable 3.5/5.5 side by side rod connector-wedding band failed when the ¿flange¿ pulled through and partially separated from each side of the implant.Only one of this part number failed, and was replaced within 10 minutes.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Visual examination of the adjust wedding band 3.5-5.5 connector revealed that the inner saddle is missing from its intended position and was not returned.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 for the adjust wedding band falling apart cannot be positively determined.However, a potential root cause may likely be that the inner cap was subjected to a higher than anticipated load resulting in the inner cap(saddle) becoming dislodged from its intended location.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: ADJUST WEDDING BAND 3.5-5.5
• Common Device Name: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 7842167
• Report Number: 1526439-2018-50822
• Device Sequence Number: 19223886
• Product Code: NKG
• UDI-Device Identifier: 10705034156774
• UDI-Public: (01)10705034156774
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K042508
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 188311302
• Device Catalogue Number: 188311302
• Device Lot Number: CA5ED46
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2018
• Initial Date Received by Manufacturer: 08/06/2018
• Supplement Date Received by Manufacturer: 09/06/2018
• Initial Report FDA Received Date: 09/04/2018
• Supplement Report FDA Received Date: 09/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 65 YR