MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG BONE SCREWS, MP, CROSS-PIN, DIAM.2.0X8MM,(5/PACKAGE); IMPLANT

Model Number	50-20708
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646)
Date of Event	08/13/2020
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 that a patient with a history of sleep apnea and bleeding underwent a lefort 1/bsso procedure on (b)(6) 2020.Patient came in for follow up visit complaining of some pain, and surgeon noticed a cross bite.Surgeon had patient scanned and determined that hardware may be loose.Surgeon removed hardware from patient¿s right and left mandible, put patient in arch bars to reestablish occlusion and fixated right and left mandible.Procedure was completed with no issues.
Event or Problem Description
It was reported that a patient with a history of sleep apnea and bleeding underwent a lefort 1/bsso procedure on (b)(6) 2020.Patient came in for follow up visit complaining of some pain, and surgeon noticed a cross bite.Surgeon had patient scanned and determined that hardware may be loose.Surgeon removed hardware from patient¿s right and left mandible, put patient in arch bars to reestablish occlusion and fixated right and left mandible.Procedure was completed with no issues.
Additional Manufacturer Narrative
The devices were not returned for evaluation.No images (e.G.X-rays) of the reported event were provided.Thus, the reported event could not be confirmed.As described in the event description, patient underwent a lefort 1/bsso on (b)(6) 2020.In a follow-up visit, patient complained of pain.A postoperative scan was performed about a week prior to the revision surgery.Surgeon has determined that device may be loose.On (b)(6) 2020, surgeon removed the reported devices and fixated right and left mandible with no reported issues.A follow-up has shown that patient¿s bone quality is good.However, it is not known if patient is compliant to post-operative care instructions.It has been also reported, that drill 50-16520 was used during procedure, the blade used during surgery however, is unknown.The drill could be used for screws with a length of up to 20mm and is intended to be used for the reported screw.Possible root causes as described in related risk management file are: hcp did not provide stable fixation; delayed healing or bad bone condition (patient incompliance).Based on statistical evaluation there is no indication for an incorrectly working product or any systematic design, material or manufacturing related issue.

• Brand Name: BONE SCREWS, MP, CROSS-PIN, DIAM.2.0X8MM,(5/PACKAGE)
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• MDR Report Key: 10504362
• Report Number: 0008010177-2020-00051
• Device Sequence Number: 3055667
• Product Code: JEY
• UDI-Device Identifier: 34546540602573
• UDI-Public: 34546540602573
• 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): 12/21/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 50-20708
• Device Catalogue Number: 50-20708
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/13/2020
• Supplement Date Received by Manufacturer: 08/13/2020
• Initial Report FDA Received Date: 09/08/2020
• Supplement Report FDA Received Date: 12/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention