MAUDE Adverse Event Report: STRYKER ORTHOBIOLOGICS-MALVERN MEDPOR CUSTOMIZED-MANDIBLE; IMPLANT

Model Number	5444-0-610
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2021
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 the company representative that during the procedure surgeon was made aware the implant was expired.The surgeon continued with implanting the implant although it is off label use.There is no further information known at this time.
Additional Manufacturer Narrative
The reported event that ¿the or staff opened the implant for the surgery, it was realized the implant had expired¿ could be confirmed.The product was designed, then approved by the surgeon and afterwards manufactured in time.At the time of procedure, the product had already expired 16 days before.The or staff recognized this during the preparation for the surgery and decided in the end to use the product and implant it.This is in contradiction to the corresponding ifu of the product (s.Labelling review).Based on the performed investigation and the dhr review there is no indication for an incorrectly working product or any systematic design, material or manufacturing related issue.H3 other text: device is implanted.
Event or Problem Description
It was reported by the company representative that during the procedure surgeon was made aware the implant was expired.The surgeon continued with implanting the implant although it is off label use.There is no further information known at this time.

• Brand Name: MEDPOR CUSTOMIZED-MANDIBLE
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOBIOLOGICS-MALVERN; 45 great valley parkway; malvern PA 19355
• MDR Report Key: 11994755
• Report Number: 0008010177-2021-00036
• Device Sequence Number: 3328399
• Product Code: FWP
• UDI-Device Identifier: 07613252457671
• UDI-Public: 07613252457671
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121315
• 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): 08/30/2021

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: 5444-0-610
• Device Catalogue Number: 54440610
• Device Lot Number: 2010291020
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/24/2021
• Supplement Date Received by Manufacturer: 05/24/2021
• Initial Report FDA Received Date: 06/14/2021
• Supplement Report FDA Received Date: 08/30/2021
• 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: Other