MAUDE Adverse Event Report: DEPUY SYNTHES SPINE EXPEDIUM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	179799740
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Fall (1848); Failure of Implant (1924); Injury (2348)
Date of Event	09/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint is a reportable adverse event and malfunction.Post-operative implant breakage reported.Changes to the construct integrity including broken, loosened, migrated devices have been known to pose risk for serious injury to the patient including risk for damage to nerve structure or the need for revision surgery.Although these events may not correlate to a device malfunction, it is often difficult to identify a specific causal event.As such, these events are always determined to be reportable events.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Not returned for evaluation.
Event or Problem Description
Revision scoliosis correction on (b)(6) 2017.Patient underwent primary correction (b)(6) 2010.Three years ago the patient had a fall and the screws broke just under the tulip and the cocr rods also broke.X-ray provided.Case is linked to (b)(4) - this case captures the instrument issues that occurred during the revision procedure.

• Brand Name: EXPEDIUM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 6908522
• Report Number: 1526439-2017-10781
• Device Sequence Number: 124598
• Product Code: NKB
• UDI-Device Identifier: 10705034083810
• UDI-Public: (01)10705034083810
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/06/2017

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: Physician
• Device Model Number: 179799740
• Device Catalogue Number: 179799740
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2017
• Initial Report FDA Received Date: 10/02/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention