MAUDE Adverse Event Report: WARSAW ORTHOPEDICS APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number	7200150
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.
Event or Problem Description
It was reported that the patient was pre-operatively diagnosed with cervical stenosis for which she underwent anterior cervical fusion at levels c4-c7.Intra-op, the plate broke.After the screws were inserted, the locking mechanism was turned and did not have a stop, it was turned more and the top part broke off.The screws were taken out and a new plate was put in and secured.No patient complication were reported for this event.
Additional Manufacturer Narrative
Visual review found one of the caps broken off from the plate.Functional evaluation found the remaining locking caps of the returned plate functioned as intended when rotated in the cw direction, and did have a positive stop.Page 18 of this system surgical technique states that this anterior cervical plate system includes an attached locking cap mechanism.The lock detail has a positive stop that prevents the cap from turning more than 90° clockwise.Avoid turning the locking cap counterclockwise as this will detach the cap from the plate.The event description does not specify direction of rotation.A search of the complaint database did not identify any additional complaint returns with this part/lot# combination.The above observations is consistent with incorrect direction of assembly.If information is provided in the future, a supplemental report will be issued.

• Brand Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 6685245
• Report Number: 1030489-2017-01660
• Device Sequence Number: 831961
• Product Code: KWQ
• UDI-Device Identifier: 00613994625069
• UDI-Public: 00613994625069
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K021461
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2017

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: 7200150
• Device Lot Number: 0199038W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2017
• Initial Date Received by Manufacturer: 06/05/2017
• Supplement Date Received by Manufacturer: 08/23/2017
• Initial Report FDA Received Date: 07/04/2017
• Supplement Report FDA Received Date: 08/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR