MAUDE Adverse Event Report: DEPUY SYNTHES SPINE ADJUST WEDDING BAND 3.5-5.5; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Catalog Number	188311302
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	12/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (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
On (b)(6) 2017 at 6:30pm, surgeon declared that implant failed due to "flange" design.
Additional Manufacturer Narrative
Product complaint # (b)(4).Visual examination found that the mountaineer adjust connector¿s components which include the rod holder and compression chip had fallen apart.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.A trend analysis was conducted.No emerging trends were found requiring further actions.A definitive root cause for the mountaineer adjust connector falling apart cannot be positively determined.However, based on the observed failure it is suggested that higher than anticipated forces were placed on the adjust connector, thus resulting in its components falling apart.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): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7170694
• Report Number: 1526439-2018-50004
• Device Sequence Number: 96916
• Product Code: NKG
• UDI-Device Identifier: 10705034156774
• UDI-Public: 10705034156774
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K042508
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2017

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 Catalogue Number: 188311302
• Device Lot Number: CA5DL86
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2017
• Initial Date Received by Manufacturer: 12/09/2017
• Supplement Date Received by Manufacturer: 01/08/2018
• Initial Report FDA Received Date: 01/07/2018
• Supplement Report FDA Received Date: 01/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1