MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS TRANSVERSE CONNECTOR; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Catalog Number	48551070
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/11/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; during tightening of transverse cross connector bottom tabs broke off.This happened 8-10 times with all sizes of cross connectors.Proper technique was follow during tightened.
Additional Manufacturer Narrative
Method: device evaluation.Result: no product issue related to the reported event was found with this product, so this is a concomitant product.Conclusion: no product issue related to the reported event was found with this product, so this is a concomitant product.
Event or Problem Description
It was reported that; during tightening of transverse cross connector bottom tabs broke off.This happened 8-10 times with all sizes of cross connectors.Proper technique was follow during tightened.

• Brand Name: OASYS TRANSVERSE CONNECTOR
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6399648
• Report Number: 0009617544-2017-00089
• Device Sequence Number: 48155
• Product Code: KWQ
• UDI-Device Identifier: 04546540371607
• UDI-Public: (01)04546540371607
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K151755
• 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): 03/22/2017

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: No Information
• Device Catalogue Number: 48551070
• Device Lot Number: X9R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/13/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/13/2017
• Supplement Report FDA Received Date: 03/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1