MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG BONE PLATE, MP, 4 HOLE, LONG BAR; IMPLANT

Model Number	55-08205
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.Product is still implanted.
Event or Problem Description
It was reported by the healthcare professional that it was noticed during a scan 3 months post operative, that the imaging showed a fracture of the titanium plate near the mandibular angle.No other information is known at this time.
Event or Problem Description
It was reported by the healthcare professional that it was noticed during a scan 3 months post operative, that the imaging showed a fracture of the titanium plate near the mandibular angle.No other information is known at this time.
Additional Manufacturer Narrative
The reported event could be confirmed as an image was received for review.The breakage could be observed at one of the fixing holes of the device implanted near the mandibular angle as well as a fracture of the mandibular angle.The mandibular angle fracture may have been the result of the plate breakage.Further information was requested from the customer (e.G.Initial implantation and revision dates, as well as the type of procedure performed).Initial implantation date is unknown.On (b)(6) 2021 , plate breakage could be confirmed.A secondary reconstruction was performed.However, the reported device used for the procedure is part of the 2.0 mp mini plating module, which is not intended for mandibular reconstruction.The mechanical strength of the reported plate is comparably lower to that of the plates intended for mandible reconstruction.As shown in the related brochure (universal 2, 9410-400-184 rev.None), the plate 55-08205 has a profile height of 1.0mm, whereas the minimum profile height of a plate for mandible reconstruction is 1.5mm.The difference of the profile heights between the 2.0 mp mini plate and reconstruction plate may have influenced the determined premature plate breakage.It was also mentioned that the implants were removed end of march 2021.In the related instructions for use (90-01939, rev.8, 2018-oct-18) ¿universal cmf and mandible implants ¿ instructions for use¿ advises against mandibular reconstruction with universal cmf implants and the use of straight plates around the mandibular angle.This case was presented to stryker¿s medical expert, as the use of a straight plate to the mandibular angle for reconstruction may have influenced the breakage.He has stated; ¿since 2.0 mp plates are not indicated for secondary reconstruction of the mandible with fibulae graft, this is off-label use.¿ in sum, the procedure to perform secondary mandibular reconstruction with 2.0 mp plates is off-label use.H3 other text : device is not available for return.

• Brand Name: BONE PLATE, MP, 4 HOLE, LONG BAR
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• MDR Report Key: 11335269
• Report Number: 0008010177-2021-00008
• Device Sequence Number: 3996420
• Product Code: JEY
• UDI-Device Identifier: 04546540602695
• UDI-Public: 04546540602695
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K022185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2021

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 Model Number: 55-08205
• Device Catalogue Number: 55-08205
• Device Lot Number: 1000373995
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/22/2021
• Supplement Date Received by Manufacturer: 01/22/2021
• Initial Report FDA Received Date: 02/16/2021
• Supplement Report FDA Received Date: 05/20/2021
• 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