MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG BONE SCREWS, MP, CROSS-PIN, DIAM.2.0X12MM,(5/PACKAGE); IMPLANT

Model Number	50-20712
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	04/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.
Event or Problem Description
It was reported by a company representative that during the patient's post operative check up, the patient presented posterior over bite on the left mandible and a non union of the left mandible.There was a revision surgery performed to remove and replace the hardware.
Additional Manufacturer Narrative
No x-rays or images of the reported event could be provided, thus the non-union could not be confirmed.As stated in the event description, the non-union has been reported about 12 weeks after initial procedure.The screws appeared to be stable and were removed during revision surgery and fixation has been placed.Prior to the reported event, the patient has missed several follow-up appointments.The sales rep also mentioned in an e-mail that the patient is non-compliant to post-operative care instructions.Based on statistical evaluation, there is no indication for an incorrectly working product or any systematic design, material or manufacturing related issue.Therefore, no further corrective and / or preventive actions are deemed necessary at this time.The complaint is added to the complaint trend.Should further information be available, the investigation will be re-evaluated.Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.H3: device is not available for evaluation.If additional information is received it will be reported on a supplemental report.
Event or Problem Description
It was reported by a company representative that during the patients post operative check up, the patient presented posterior over bite on the left mandible and a non union of the left mandible.There was a revision surgery performed to remove and replace the hardware.

• Brand Name: BONE SCREWS, MP, CROSS-PIN, DIAM.2.0X12MM,(5/PACKAGE)
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; DE D-79111
• MDR Report Key: 10065217
• Report Number: 0008010177-2020-00023
• Device Sequence Number: 777474
• Product Code: JEY
• UDI-Device Identifier: 34546540602597
• UDI-Public: 34546540602597
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K022185
• 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): 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 50-20712
• Device Catalogue Number: 50-20712
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/29/2020
• Supplement Date Received by Manufacturer: 04/29/2020
• Initial Report FDA Received Date: 05/18/2020
• Supplement Report FDA Received Date: 07/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1