MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXP 635 SS LAT CONN 50 MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	189692050
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	08/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Visual examination found that the tulip head portion of the connector had cracked.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.A definitive root cause for the tulip head portion of the connector cracking cannot be positively determined.However, observed damage suggests that a possible cause for the fracture may have likely occurred due to a high unanticipated load stress.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends were found, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that dr.(b)(6) was doing a revision on the patient on monday (b)(6) 2018, he implanted another rod with open 6.35 connectors.This implantation procedure was unilateral.Upon exploration, he saw the set screw was extremely loose.Once he gained better exposure, he saw the threaded area of the lateral connector splayed.After removing the lateral connector, he saw the base cracked.Dr.(b)(6) replaced the connector with a new one.(1896-92-050).

• Brand Name: EXP 635 SS LAT CONN 50 MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 7894504
• Report Number: 1526439-2018-50901
• Device Sequence Number: 1395642
• Product Code: NKB
• UDI-Device Identifier: 10705034180175
• UDI-Public: (01)10705034180175
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K062174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/27/2018

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: 189692050
• Device Catalogue Number: 189692050
• Device Lot Number: UI135061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/27/2018
• Initial Report FDA Received Date: 09/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 31 YR