MAUDE Adverse Event Report: STRYKER GMBH NON LOCKING SCREW ANCHORAGE Ø3.5MM / L22MM; PLATE, FIXATION, BONE

Catalog Number	PLSS3522
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	05/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
Surgeon reported that he removed a anchorage plate on (b)(6) 2019.On removal he noticed what appeared to darkened tissue around the plate and screw interface.
Additional Manufacturer Narrative
Investigation revealed the subject product to be a concomitant item.The device did not contribute to the reported event.If any additional information is provided indicating otherwise the record will be reopened and the investigation will be reworked.
Event or Problem Description
Surgeon reported that he removed a anchorage plate on friday (b)(6) 2019.On removal he noticed what appeared to darkened tissue around the plate and screw interface.

• Brand Name: NON LOCKING SCREW ANCHORAGE Ø3.5MM / L22MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8675266
• Report Number: 0008031020-2019-00529
• Device Sequence Number: 2220655
• Product Code: HRS
• UDI-Device Identifier: 07613252262961
• UDI-Public: 07613252262961
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K083447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2019

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: Lay User/Patient
• Device Catalogue Number: PLSS3522
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/08/2019
• Supplement Date Received by Manufacturer: 07/23/2019
• Initial Report FDA Received Date: 06/06/2019
• Supplement Report FDA Received Date: 08/20/2019
• 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
• Patient Age: 46 YR