MAUDE Adverse Event Report: DEPUY SPINE INC MNTR OC PLATE MEDIUM; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Catalog Number	188362037
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Not Applicable (3189)
Date of Event	01/19/2018
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
Ohe of the mountaineer oc inner screws wouldn¿t seat properly at the end of the case, during final tightening.Dr.(b)(6) had to remove the plate, washer, and occipital screws.He then replaced all the items with new implants.Patient consequence? yes.Patient consequence description: added time (20 minutes) to surgery, no patient injury.Action taken for procedure: asked surgeon to replace the first stripped oc setscrew.He attempted this three times before deciding to remove and replace the occipital implants.
Additional Manufacturer Narrative
Product complaint # (b)(4).Visual examination of the mntr oc plate medium revealed that one of the screw tabs threads were torn and shredded off from the plate body.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.A definitive root cause for the threads being torn on the mntr oc plate medium cannot be determined.A potential root cause could be due to inadvertently cross-threading the set screw with the screw on the plate.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: MNTR OC PLATE MEDIUM
• Common Device Name: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7234147
• Report Number: 1526439-2018-50097
• Device Sequence Number: 19331484
• Product Code: NKG
• UDI-Device Identifier: 10705034158884
• UDI-Public: 10705034158884
• Combination Product (Y/N): N
• PMA/510(K) Number: K042508
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2018

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 Catalogue Number: 188362037
• Device Lot Number: WA3616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2018
• Initial Date Received by Manufacturer: 01/20/2018
• Supplement Date Received by Manufacturer: 02/22/2018
• Initial Report FDA Received Date: 02/01/2018
• Supplement Report FDA Received Date: 02/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 28 YR