(b)(4).Concomitant medical products: catalog number: 00-0903-2660, 3.5mm locking cortical screw with t15 hex, size 60mm, lot number: unknown; catalog number: 00-0903-2655, 3.5mm locking cortical screw with t15 hex, size 55mm, lot number: unknown.Foreign source - (b)(6).Customer has indicated that the product will not be returned to orthopediatrics for investigation as is remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 3006460162-2018-00005 and 3006460162-2018-00006.
|